FrancophonIA/ELRC3.0 huggingface dataset:
English: Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 1.2 micrometre or less).
Maltese: Uża biss sett tal-infużjoni li jkollu filtru fil-pajp, sterili, li ma jikkawżax id-deni, u li jeħel miegħu livell baxx ta' proteini (daqs tal-pori 1.2 mikrometru jew inqas).
English: The solution may develop a few fine translucent particles, as infliximab is a protein.
Maltese: Is-soluzzjoni tista' tifforma ftit frak transluċidu, peress li infliximab huwa proteina.
English: Of infliximab-treated patients who had an infusion reaction during the induction period, through week 6, 27% experienced an infusion reaction during the maintenance period, week 7 through week 54.
Maltese: Millpazjenti kkurati b'infliximab li kellhom reazzjoni għall-infużjoni waqt il-perjodu ta' induzzjoni sa ġimgħa 6, 27% kellhom reazzjoni marbuta mal-infużjoni waqt il-perjodu ta' manteniment, minn ġimgħa 7 sa ġimgħa 54.
English: Bullous eruption, seborrhoea, rosacea, skin papilloma, hyperkeratosis, abnormal skin pigmentation.
Maltese: Joħorġu l-imsiemer, seborreja, rosaċeja, papilloma tal-ġilda, iperkeratożi, kulur tal-ġilda anormali
English: Discontinuation of immunomodulators and corticosteroid taper were permitted after week 0.
Maltese: Twaqqif talimmunomodulaturi u tnaqqis bil-mod tal-kortikosterojdi kienu permessi wara ġimgħa 0.
English: • Signs of infection (including TB) such as fever, feeling tired, cough which may be persistent, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, collection of pus in the gut or around the anus (abscess), dental problems or burning sensation when urinating
Maltese: • Sinjali ta' infezzjoni (inkluża TB) bħal deni, tħossok għajjien, sogħla li tista' tkun persistenti , qtugħ ta' nifs, sintomi bħal tal-influwenza, telf tal-piż, issir għarqan/a bil-lejl, dijarea, ġrieħi, tinġabar il-materja fl-intern jew madwar l-anus (axxess), problemi fis-snien jew tħoss ħruq meta tgħaddi l-awrina
English: Flixabi treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, inflammatory bowel diseases, ankylosing spondylitis, psoriatic arthritis or psoriasis.
Maltese: Il-kura b'Flixabi għandha tibda u tkun issorveljata minn tobba kkwalifikati b'esperjenza tad-dijanjosi u l-kura ta' artrite rewmatojde, mard infjammatorju tal-musrana, ankylosing spondylitis, artrite psorijatika jew psorjasi.
English: ≥ 3 x ULN
Maltese: Punteġġ totali d
English: Infusion reactions following re-administration of infliximab A clinical study in patients with moderate to severe psoriasis was designed to assess the efficacy and safety of long-term maintenance therapy versus re-treatment with an induction regimen of infliximab (maximum of four infusions at 0, 2, 6 and 14 weeks) following disease flare.
Maltese: Reazzjonijiet għall-infużjoni wara l-għoti mill-ġdid ta' infliximab Studju kliniku f'pazjenti bi psorjasi moderata sa severa kien maħsub biex tiġi evalwata l-effikaċja u ssigurtà ta' terapija fit-tul kontra kura mill-ġdid b'kors ta' induzzjoni ta' infliximab (massimu ta' erba' infuzjonijiet f'ġimgħat 0, 2 6 u 14) wara li tkun ħraxet il-marda.
English: New onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), urticaria, rash, pruritus, hyperhidrosis,
Maltese: Bidu ġdid ta' psorjasi jew taggrava inkluż psorjasi bl-imsiemer (laktar fil-pala tal-idejn u s-saqajn), urtikarja, raxx, ħakk, iperidrożi, ġilda xotta, dermatite fungali, ekżema, alopeċja.
English: Week 50
Maltese: Ġimgħa 50
English: • Treatment with TNF blockers such as Flixabi may result in reactivation of hepatitis B virus in patients who carry this virus, which can be life-threatening in some cases.
Maltese: • Kura b'imblokkaturi ta' TNF bħal Flixabi tista' tikkawża attivazzjoni mill-ġdid tal-virus tal epatite B f'pazjenti li jġorru dan il-virus li tista' tkun ta' theddida għall-ħajja f'xi każijiet.
English:  treatment of fistulising, active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).
Maltese: • kura tal-marda ta' Crohn attiva fistulizzanti, f'pazjenti adulti li ma kellhomx rispons minkejja kors sħiħ u adegwat ta' terapija b'kura konvenzjonali (li tinkludi antibijotiċi, tneħħija ta' likwidu u terapija immunosoppressiva).
English: Paediatric Crohn's disease
Maltese: Marda ta' Crohn Pedjatrika
English: België/Belgique/Belgien Biogen Belgium NV/S.A Tél/Tel: + 32 (0)2 808 5947
Maltese: Tél/Tel: + 32 (0)2 808 5947
English: Children and adolescents who took infliximab for Crohn's disease showed some differences in side effects compared with adults who took infliximab for Crohn's disease.
Maltese: Tfal u adolexxenti li ħadu infliximab għal marda ta' Crohn urew xi differenzi fl-effetti sekondarji meta mqabbla ma' persuni adulti li ħadu infliximab għall-marda ta' Crohn.
English: Currently available data are described in section 5.2 but no recommendation on a posology can be made.
Maltese: Data disponibbli hi deskritta fis-sezzjoni 5.2 iżda ma tista' ssir l-ebda rakkomandazzjoni dwar il-pożoloġija.
English: Tell your doctor straight away if you get symptoms of liver problems during treatment with Flixabi.
Maltese: Għid lit-tabib tiegħek minnufih jekk ikollok sintomi ta' problemi fil-fwied matul it-trattament b'Flixabi.
English: Endoscopic studies of intestinal mucosa have shown evidence of mucosal healing in infliximab-treated patients.
Maltese: Studji endoskopiċi tal-mukuża tal-imsaren wrew evidenza ta' fejqan tal-mukuża f'pazjenti kkurati b'infliximab.
English: Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNFα but not to lymphotoxin α (TNFβ).
Maltese: Jekk issir dijanjosi ta' tuberkulożi mhux attiva (‘moħbija') terapija kontra t-tuberkulożi moħbija għandha tinbeda b'terapija kontra t-tuberkulożi qabel ma' jinbeda Flixabi, u skont irrakkomandazzjonijiet lokali.
English: Infections were reported more frequently for subjects who received q8 week as opposed to q12 week infusions (73.6% and 38.0%, respectively), while serious infections were reported for 3 subjects in the q8 week and 4 subjects in the q12 week maintenance treatment group.
Maltese: Infezzjonijiet kienu rrappurtati b'mod aktar frekwenti għal individwi li rċevew ġimgħa q8 għall-kuntrarju ta' ġimgħa q12 (73.6% u 38.0%, rispettivament), filwaqt li infezzjonijiet serji kienu rrappurtati fi 3 individwi f'ġimgħa q8 u 4 individwi fil-grupp ta' manteniment f'ġimgħa q12. Linfezzjonijiet li kienu rrappurtati b'mod l-aktar komuni kienu infezzjonijiet tal-parti ta' fuq tal-passaġġ respiratorju u farinġite, u l-aktar infezzjoni serja li kienet irrappurtata b'mod l-aktar komuni kienet axxess.
English: Results from week 54 are shown in Table 4.
Maltese: °C kienet aċċertata għal 24 siegħa.
English: * P-values represent each infliximab treatment group vs. AZA monotherapy
Maltese: * Il-valuri P jirrappreżentaw kull grupp ta' kura b'infliximab vs. terapija b'AZA waħdu.
English: st dose
Maltese: Marda ta'
English: Vaginitis.
Maltese: Tilqim
English: Store in a refrigerator Can be stored at room temperature (up to 25°C) for a single period up to 6 months.
Maltese: Jista' jinħażen fit-temperatura tal-kamra (sa 25°C) għal perjodu wieħed sa 6 xhur.
English: Patients in both studies had plaque psoriasis (Body Surface Area [BSA] ≥ 10% and Psoriasis Area and Severity Index [PASI] score ≥ 12).
Maltese: Il-pazjenti fiż-żewġ studji kellhom psorjasi talplakka (Erja tas-Superfiċje tal-Ġisem [BSA] ≥ 10% u punteġġ tal-Indiċi tas-Severità u l-Erja tal
English: Reproductive system and breast disorders Uncommon:
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Mhux komuni:
English: Concurrent administration of TNF-alpha inhibitor and anakinra Serious infections and neutropenia were seen in clinical studies with concurrent use of anakinra and another TNFα-blocking agent, etanercept, with no added clinical benefit compared to etanercept alone.
Maltese: F'pazjenti li qed jirċievu terapija kontra TNF, hemm disponibbli tagħrif limitat dwar ir-rispons għattilqima b'vaċċini ħajjin jew fuq it-trasmissjoni sekondarja ta' infezzjoni mill-vaċċini ħajjin.
English: Periodic screening should continue in women treated with infliximab, including those over 60 years of age.
Maltese: Ittestjar perjodiku għandu jkompli f'nisa ttrattati b'infliximab, inklużi f'dawk b'età ta' aktar minn 60 sena.
English: Patients who did not respond to infliximab at week 8 (n=15) received no further medicinal product and returned for safety followup.
Maltese: Pazjenti li ma rrispondewx għal infliximab f'ġimgħa 8 (n=15) ma rċevewx aktar prodott mediċinali u rritornaw għallvista ta' sigurtà.
English: TNF alpha is involved in inflammatory processes of the body so blocking it can reduce the inflammation in your body.
Maltese: Għalhekk, dejta preklinika konvenzjonali dwar s-sigurtà ta' infliximab hija limitata.
English: In clinical studies, delayed hypersensitivity reactions have been uncommon and have occurred after infliximab-free intervals of less than 1 year (see sections 4.4 and 4.8).
Maltese: Fi studji kliniċi, reazzjonijiet ta' sensittività eċċessiva li damu ma seħħew ma kinux komuni u seħħew wara intervalli mingħajr l-użu ta' infliximab ta' anqas minn sena (ara sezzjoni 4.4 u 4.8).
English: Flixabi and Orencia should not be used together.
Maltese: Flixabi u Orencia m'għandhomx jintużaw flimkien.
English: Analysis of lamina propria mononuclear cells obtained by biopsy of the intestinal mucosa showed that infliximab treatment caused a reduction in the number of cells capable of expressing TNFα and interferon γ.
Maltese: Analiżi ta' ċelluli mononukleari tal-lamina propria miksuba permezz ta' bijopsija tal-mukuża tal-musrana wriet li kura b'infliximab ikkawżat tnaqqis fin-numru ta' ċelluli li kienu kapaċi jesprimu TNFα u interferon γ.
English: In patients treated with Flixabi, an invasive fungal infection such as aspergillosis, candidiasis, pneumocystosis, histoplasmosis, coccidioidomycosis or blastomycosis should be suspected if they develop a serious systemic illness, and a physician with expertise in the diagnosis and treatment of invasive fungal infections should be consulted at an early stage when investigating these patients.
Maltese: F'pazjenti kkurati b'Flixabi, infezzjoni invażiva ta' fungu bħal asperġillożi, kandidijasi, pnewmoċistożi, istoplasmożi, kokkidjoidomikożi jew blastomikożi għandhom ikunu ssuspettati jekk jiżviluppaw mard sistemiku serju, u tabib espert fid-dijanjosi u kura ta' infezzjonijiet invażivi fungali għandu jiġi kkonsultat fi stadju bikri meta wieħed ikun qed jeżamina dawn il-pazjenti.
English: Package sizes
Maltese: Daqs tal-pakkett
English: Bottle (HDPE) 1 bottle of 180 tablets without outer carton
Maltese: Flixkun ta' 180 pillola mingħajr kartuna ta' barra
English: Invented name Strengths Pharmaceutical Forms Route of Administration Packaging
Maltese: Numru ta' l-EU Isem inventat Qawwa Għamla farmaċewtika
English: Date of opening:___________
Maltese: Data tal-ftuħ:___________
English: P-value a, b mITT Analysis
Maltese: P-value a, b
English: Film coating: hypromellose 5 cP, titanum dioxide (E171), macrogol, indigo carmine aluminium lake (E132).
Maltese: Il-kisja tal-pillola: hypromellose 5 cP, titanum dioxide (E171), macrogol, indigo carmine aluminium lake (E132).
English: (see section 4.4).
Maltese: disponibbli (ara sezzjoni 4.4).
English: NC = not calculated.
Maltese: NC = mhux ikkalkulat (not calculated).
English: Pregelatinized starch Croscarmellose sodium Lactose monohydrate Microcrystalline cellulose Sodium stearyl fumarate Stearic acid
Maltese: Il-qalba tal-pillola Pregelatinized starch Croscarmellose sodium Lactose monohydrate Microcrystalline cellulose Sodium stearyl fumarate Stearic acid
English: % difference (95%CI)
Maltese: Differenza (95%CI)
English: Tablet core: pregelatinized starch, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, sodium stearyl fumarate, stearic acid.
Maltese: Il-qalba tal-pillola: pregelatinized starch, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, sodium stearyl fumarate, stearic acid.
English: BLISTER (OPA/Alu/PE+DES-Alu FOIL)
Maltese: FOLJI (OPA/Alu/PE+DES/ - Folji tal-aluminju)
English: Lamivudine and
Maltese: Lamivudine u
English: Tenofovir disoproxil is converted in vivo to tenofovir, a nucleoside monophosphate (nucleotide) analogue of adenosine monophosphate.
Maltese: Tenofovir disoproxil jinbdel in vivo għal tenofovir, li huwa analogu ta' nucleoside monophosphate (nucleotide) ta' adenosine monophosphate.
English: HIV-1 RNA < 400 copies/mL (TLOVR)
Maltese: RNA tal-HIV-1 < 400 kopja/mL (TLOVR)
English: Date of first authorisation: 8 December 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 8 ta' Diċembru 2016
English: Race, N (%)
Maltese: Sess, N (%) Raġel
English: Contains also lactose monohydrate.
Maltese: Fih ukoll lactose monohydrate.
English: ANTI-INFECTIVES Hepatitis B virus (HBV) antiviral agents Adefovir dipivoxil /Tenofovir disoproxil
Maltese: Aġenti antivirali tal-virus tal-epatite B (HBV) Adefovir dipivoxil /Tenofovir disoproxil
English: The degree of renal impairment was defined according to baseline creatinine clearance (CrCl) (normal renal function when CrCl > 80 mL/min; mild impairment with CrCl = 50-79 mL/min; moderate impairment with CrCl = 30-49 mL/min and severe impairment with CrCl = 10-29 mL/min).
Maltese: Il-grad ta' indeboliment renali kien definit skond il-linja bażi tattneħħija tal-kreatinina (CrCl) (funzjoni renali normali meta CrCl > 80 mL/min; indeboliment ħafif b'CrCl = 50-79 mL/min; indeboliment moderat b'CrCl = 30-49 mL/min u indeboliment sever b'CrCl = 10-29 mL/min).
English: At baseline the randomised groups had similar median plasma HIV-1 RNA (5.02 and 5.00 log10 copies/mL) and CD4 counts (233 and 241 cells/mm
Maltese: Fil-linja bażi, il-gruppi randomised kellhom medjan simili ta' l-RNA tal-HIV-1 tal-plażma (5.02 u 5.00 log10 kopja/mL) u ta' l- għadd tas-CD4 (233 u 241 ċelluli/mm
English: The predominant circulating metabolite of sofosbuvir.
Maltese: Il-metabolit predominanti ta' sofosbuvir fiċ-ċirkolazzjoni.
English: Immunodeficiency Virus (HIV) Infection' - PrEP reminder card
Maltese: l-immunodefiċjenza Uman (HIV)' - Skeda ta' tfakkir għal PrEP
English: - Genotypic resistance to efavirenz, predominantly the K103N mutation, developed in virus from 13/19 (68%) patients in the emtricitabine/tenofovir disoproxil /efavirenz group and in virus from 21/29 (72%) patients in the comparative group.
Maltese: - Ir-reżistenza ġenotipika għal efavirenz, l-aktar il-mutazzjoni K103N, żviluppat f'virus f'13/19 (68%) tal-pazjenti fil-grupp ta' emtricitabine/tenofovir disoproxil/efavirenz u f'virus f'21/29 (72%) tal-pazjenti fil-grupp komparattiv.
English: Subjects were followed for 4,237 personyears.
Maltese: L-individwi kienu segwiti għal 4,237 sena ta' persuna.
English: Moderate renal impairment (CrCl 3049 mL/min)
Maltese: Indeboliment tal-kliewi moderat (CrCl 30-49 mL/min)
English: Placebo Tenofovir disoproxil 245 mg +Emtricitabine/tenofovir disoproxil
Maltese: Tenofovir disoproxil 245 mg+ emtricitabine/tenofovir disoproxil
English: See section 2 "Emtricitabine/Tenofovir disoproxil Krka contains lactose", "Emtricitabine/Tenofovir disoproxil Krka contains sodium".
Maltese: Ara sezzjoni 2 "Emtricitabine/Tenofovir disoproxil Krka fih lactose", "Emtricitabine/Tenofovir disoproxil Krka fih sodium".
English: Pack sizes: 30 film coated tablets (1x30) and 90 film-coated tablets (3x30).
Maltese: Daqs tal-pakkett: 30 pillola miksija b'rita (1 x 30) u 90 pillola miksija b'rita (3 x 30).
English: Antiretrovirals
Maltese: ANTI-INFETTIVI Antiretrovirali
English: The pharmacokinetics of emtricitabine and tenofovir (administered as tenofovir disoproxil) are expected to be similar in HIV-1 infected and uninfected adolescents based on the similar exposures of emtricitabine and tenofovir in HIV-1 infected adolescents and adults, and the similar exposures of emtricitabine and tenofovir in HIV-1 infected and uninfected adults.
Maltese: Il-farmakokinetika ta' emtricitabine u tenofovir (mogħti bħala tenofovir disoproxil) huma mistennija li jkunu simili f'adolexxenti infettati u mhux infettati bl-HIV-1 abbażi tal-esponimenti simili għal emtricitabine u tenofovir f'adolexxenti u adulti infettati bl-HIV-1, u l-esponimenti simili għal emtricitabine u tenofovir f'adulti infettati u mhux infettati bl-HIV-1.
English: vesiculobullous rash, pustular rash, maculopapular rash, rash, pruritus, urticaria, skin discolouration (increased pigmentation)
Maltese: raxx vesikulobullożu, raxx bil-ponot, raxx makulari bl-imfafet, raxx, ħakk, urtikarja, telf tal-kulur tal-ġilda (żieda fil-pigmentazzjoni)
English: tenofovir diphosphate competitively inhibit HIV-1 reverse transcriptase, resulting in DNA chain termination.
Maltese: Emtricitabine triphosphate u tenofovir diphosphate jinibixxu kompetittivament ir-reverse transcriptase ta' l-HIV-1 li jirriżulta fit-terminazzjoni tal-katina tad-DNA.
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 kull 89 pazjent pedjatriku (9.0%) esposti għal tenofovir disoproxil waqqfu l-mediċina tal-istudju minħabba avvenimenti avversi renali.
English: - No virus analysed contained the K65R or K70E mutation.
Maltese: - L-ebda virus li kien analizzat ma kien fih il-mutazzjoni K65R jew K70E.
English: Emtricitabine/Tenofovir disoproxil Krka is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1).
Maltese: Emtricitabine/Tenofovir disoproxil Krka huwa indikat f'terapija antiretrovirali kombinata għal trattament ta' adulti infettati b'HIV-1 (ara sezzjoni 5.1).
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: Ilkategorija 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: - Additional risk minimisation measures
Maltese: • Miżuri addizzjonali għall-minimizzazzjoni tar-riskji
English: The mean (%CV) tenofovir Cmax and AUC0-∞ values were 223 (34.8%) ng/mL and 2,050 (50.8%) ng•h/mL, respectively, in normal subjects compared with 289 (46.0%) ng/mL and 2,310 (43.5%) ng•h/mL in subjects with moderate hepatic impairment, and 305 (24.8%) ng/mL and 2,740 (44.0%) ng•h/mL in subjects with severe hepatic impairment.
Maltese: Il-medja (%CV) tal-valuri ta' Cmax u l-valuri ta' l-AUC0-∞ ta' tenofovir kienu ta' 223 (34.8%) ng/mL u 2,050 (50.8%) ng•h/mL rispettivament, f'individwi normali, meta pparagunata ma' 289 (46.0%) ng/mL u 2,310 (43.5%) ng•h/mL f'individwi b'indeboliment epatiku moderat, u 305 (24.8%) ng/mL u 2,740 (44.0%) ng•h/mL f'individwi b'indeboliment epatiku sever.
English: HIV-1 infection: The most frequently reported adverse reactions considered possibly or probably related to emtricitabine and/or tenofovir disoproxil were nausea (12%) and diarrhoea (7%) in an openlabel randomised clinical study in adults (GS-01-934, see section 5.1).
Maltese: L-iktar reazzjonijiet avversi li kienu rrappurtati b'mod frekwenti u li kienu kkunsidrati bħala possibbilment jew probabbilment relatati ma' emtricitabine u/jew tenofovir disoproxil, kienu t-tqalligħ (12%) u d-dijarea (7%) fi studju kliniku open-label u randomised fl-adulti (GS-01-934, ara sezzjoni 5.1).
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: Insuffiċjenza tal-kliewi, indeboliment tal-kliewi, żieda filkreatinina, ipofosfatemija u tubulopatija prossimali (inkluża s-sindrome ta' Fanconi) kienu rrappurtati bl-użu ta' tenovir disoproxil (ara sezzjoni 4.8).
English: 3 and +196 cells/mm
Maltese: +196 ċelluli/mm 3, rispettivament.
English: The mean (%CV) emtricitabine drug exposure increased from 12 (25%) µg•h/mL in subjects with normal renal function, to 20 (6%) µg•h/mL, 25 (23%) µg•h/mL and 34 (6%) µg•h/mL, in subjects with mild, moderate and severe renal impairment, respectively.
Maltese: L-esponiment medju tal-mediċina ta' emtricitabine (%CV) żdied minn 12 (25%) µg•h/mL f'individwi b'funzjoni renali normali, għal 20 (6%) µg•h/mL, 25 (23%) µg•h/mL u 34 (6%) µg•h/mL, f'individwi b'indeboliment ħafif, moderat u sever rispettivament.
English: Age (Yrs), Median (Q1, Q3) Gender, N (%)
Maltese: Età (Snin), Medjana (Q1, Q3)
English: Emtricitabine/Tenofovir disoproxil Krka contains lactosemonohydrate.
Maltese: Emtricitabine/Tenofovir disoproxil Krka fih lactose monohydrate.
English: In vivo -pre-exposure prophylaxis: Plasma samples from 2 clinical studies of HIV-1 uninfected subjects, iPrEx and Partners PrEP, were analysed for 4 HIV-1 variants expressing amino acid substitutions (i.e. K65R, K70E, M184V, and M184I) that potentially confer resistance to tenofovir or emtricitabine.
Maltese: Kampjuni tal-plażma minn 2 studji kliniċi ta' individwi mhux infettati bl-HIV-1, iPrEx u Partners PrEP, kienu analizzati għal 4 varjanti tal-HIV-1 li jesprimu sostituzzjonijiet tal-aċidi amminiċi (jiġifieri K65R, K70E, M184V, u M184I) li potenzjalment jikkonferixxu reżistenza għal tenofovir jew emtricitabine.
English: Table 2: Interactions between emtricitabine/tenofovir disoproxil or its individual component(s) and other medicinal products
Maltese: Tabella 2: Interazzjonijiet bejn il-komponenti individwali ta' emtricitabine/tenofovir disoproxil u prodotti mediċinali oħra
English: The Partners PrEP clinical study (CO-US-104-0380) evaluated emtricitabine/tenofovir disoproxil, tenofovir disoproxil 245 mg, or placebo in 4,758 HIV-uninfected subjects from Kenya or Uganda in serodiscordant heterosexual couples.
Maltese: L-istudju kliniku Partners PrEP (CO-US-104-0380) evalwa emtricitabine/tenofovir disoproxil, tenofovir disoproxil 245 mg, jew plaċebo f'4,758 individwu mhux infettati bl-HIV mill-Kenja jew lUganda f'koppji eterosesswali serodiskordanti.
English: Treatment of HIV-1 infection: In an open-label randomised clinical study (GS-01-934), antiretroviralnaïve HIV-1 infected adult patients received either a once daily regimen of emtricitabine, tenofovir disoproxil and efavirenz (n = 255) or a fixed combination of lamivudine and zidovudineadministered twice daily and efavirenz once daily (n = 254).
Maltese: Fi studju kliniku open-label u randomised (GS-01-934), pazjenti adulti infettati bl-HIV-1 li qatt ma' kienu ngħataw mediċini antiretrovirali qabel irċievew jew kors ta' darba kuljum ta' emtricitabine, tenofovir disoproxil u efavirenz (n=255), jew kumbinazzjoni fissa ta' lamivudine u zidovudine mogħti darbtejn kuljum, u efavirenz mogħti darba kuljum (n=254).
English: 'Case' = HIV seroconverter; 'Cohort' = 100 randomly selected subjects from each of the tenofovir disoproxil 245 mg and emtricitabine/tenofovir disoproxil groups.
Maltese: ‘Każ' = serokonvertitur tal-HIV; ‘Koorti' = 100 individwu magħżulin b'mod każwali minn kull wieħed mill-gruppi ta' tenofovir disoproxil 245 mg u emtricitabine/tenofovir disoproxil.
English: AUC: ↓ 25% (↓ 42 to ↓ 3) Cmax: ↓ 28% (↓ 50 to ↑ 5) Cmin: ↓ 26% (↓ 46 to ↑ 10) Tenofovir:
Maltese: AUC: ↓ 25% (↓ 42 għal ↓ 3) Cmax: ↓ 28% (↓ 50 għal ↑ 5) Cmin: ↓ 26% (↓ 46 għal ↑ 10) Tenofovir:
English: 30 film-coated tablets: EU/1/16/1151/002 90 (3 x 30) film-coated tablets: EU/1/16/1151/004
Maltese: EU/1/16/1151/002 90 (3 x 30) pillola miksija b'rita:
English: Antimycobacterials Rifampicin/Tenofovir disoproxil
Maltese: Antimikobatterjali Rifampicin /Tenofovir disoproxil