FrancophonIA/ELRC3.0 huggingface dataset:
English: Immune reconstitution inflammatory syndrome (IRIS) Out of 153 subjects, two subjects developed immune reconstitution inflammatory syndrome (IRIS; see section 4.4) manifested as an exacerbation of progressive multifocal leukoencephalopathy (serious) and of cryptococcal cutaneous infection (serious), respectively.
Maltese: Mill-153 individwu, żewġ individwi żviluppaw sindrome infjammatorju ta' rikostituzzjoni immunitarja (IRIS; ara sezzjoni 4.4) li deher bħala aggravar ta' lewkoenċefalopatija multifokali progressiva (serja) u ta' infezzjoni tal-ġilda kriptokokkali (serja), rispettivament.
English: Proportion of subjects achieving a ≥ 0.5 log10
Maltese: ≥ 0.5 log10 fit-tagħbija virali
English: Hydrochloric acid (for pH-adjustment) Water for injections
Maltese: Hydrochloric acid (għall-aġġustament tal-pH)
English: This is because Trogarzo has not been studied in this age group.
Maltese: Dan għaliex Trogarzo ma ġiex studjat f'dan il-grupp ta' età.
English: After the infusion is complete, flush with 30 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
Maltese: Wara li titlesta l-infużjoni, laħlaħ b'30 mL ta' sodium chloride 9 mg/mL (0.9 %) soluzzjoni għallinjezzjoni.
English: The volume of distribution of ibalizumab is approximately 4.8 L, which is comparable with vascular space, based on the performed population pharmacokinetics analysis.
Maltese: Il-volum ta' distribuzzjoni ta' ibalizumab huwa ta' madwar 4.8 L, li huwa komparabbli mal-ispazju vaskulari, ibbażat fuq l-analiżi tal-farmakokinetika tal-popolazzjoni li saret.
English: Immune system disorders hypersensitivity, immune reconstitution inflammatory syndrome (see below and section 4.4)
Maltese: Disturbi fis-sistema immunitarja sensittività eċċessiva, sindrome infjammatorju ta' rikostituzzjoni immunitarja (ara hawn taħt u sezzjoni 4.4)
English: Subjects all received OBR plus 1 of the following regimens: alternating intravenous (IV) infusions of 15 mg/kg ibalizumab and placebo, weekly for the first 9 doses (through the Week 8 visit), then IV infusions of 15 mg/kg ibalizumab every 2 weeks (Arm A); 10 mg/kg ibalizumab IV infusions weekly for the first 9 doses (through the Week 8 visit), then IV infusions of 10 mg/kg ibalizumab every 2 weeks (Arm B); or weekly placebo IV infusions for the first 9 doses (through the Week 8 visit), then IV infusions of placebo every 2 weeks (Placebo arm).
Maltese: L-individwi kollha rċevew OBR u 1 mill-korsijiet li ġejjin: infużjonijiet ġol-vini (IV) alternati ta' 15 mg/kg ibalizumab u plaċebo, kull ġimgħa għall-ewwel 9 dożi (sal-vista ta' Ġimgħa 8), imbagħad infużjonijiet IV ta' 15 mg/kg ibalizumab kull ġimagħtejn (Fergħa A); infużjonijiet IV ta' 10 mg/kg ibalizumab kull ġimgħa għallewwel 9 dożi (sal-vista ta' Ġimgħa 8), imbagħad infużjonijiet IV ta' 10 mg/kg ibalizumab kull ġimagħtejn (Fergħa B); jew infużjonijiet IV tal-plaċebo kull ġimgħa għall-ewwel 9 dożi (sal-vista ta' Ġimgħa 8), imbagħad infużjonijiet IV tal-plaċebo kull ġimagħtejn (fergħa tal-Plaċebo).
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: Filwaqt li soppressjoni virali effettiva b'terapija antiretrovirali ntweriet li tnaqqas sostanzjalment ir riskju ta' trażmissjoni sesswali, ma jistax jiġi eskluż riskju residwali.
English: IRIS was reported in 2 subjects out of 153 treated with ibalizumab in Phase 2b and 3 clinical studies (see section 4.8).
Maltese: IRIS ġie rrappurtat f'żewġ individwi minn 153 ikkurati b'ibalizumab fl-istudji kliniċi ta' Fażi 2b u 3 (ara sezzjoni 4.8).
English: Trogarzo 200 mg concentrate for solution for infusion ibalizumab
Maltese: Trogarzo 200 mg konċentrat għal soluzzjoni għall-infużjoni ibalizumab
English: For intravenous use.
Maltese: “antiretrovirali”.
English: 4 vials (5.32 mL)
Maltese: 32 mL)
English: There were no ibalizumab-related adverse effects (maternal, foetal, or infant) at 110 mg/kg (No-Observed-Adverse-Effect Level, NOAEL).
Maltese: Ma kien hemm l-ebda effett avvers relatat ma' ibalizumab (matern, fetali, jew tat-tarbija) b'110 mg/kg (Livell Bla Effett Ħażin Osservat, NOAEL).
English: An increase in the mean number of CD4+ T-cells of 62 cells/mm3 was observed from Baseline to Week 25 (Intent-To-Treat (ITT) analysis).
Maltese: Ġiet osservata żieda fl-għadd medju ta' ċelloli CD4+ T ta' 62 ċellola/mm3 mil-Linja Bażi sal-Ġimgħa 25 (analiżi ta' Intenzjonat
English: Virologic response at week 25 by baseline CD4 cell count, integrase inhibitor resistance and Overall Susceptibility Score (OSS)* for study TMB-301
Maltese: Tabella 3. Ir-rispons viroloġiku fil-ġimgħa 25 skont l-għadd ta' ċelloli CD4 fil-linja bażi, irreżistenza tal-inibitur tal-integrażi u l-Punteġġ ta' Suxxettibilità Globali (OSS)* għall istudju TMB-301
English: However, CD4+ cells in infants of treated females were temporarily suppressed from BD14-91 compared to control, but there was no further impact on immunocompetence of the infants.
Maltese: iċ-ċelloli CD4+ fit-trabi ta' nisa kkurati ġew soppressi temporanjament mill-BD14-91 meta mqabbla mal-kontroll, iżda ma kien hemm l-ebda impatt ulterjuri fuq l-immunokompetenza tat-trabi.
English: One subject out of 153 was reported to have hypersensitivity (allergic reaction) on Day 21 (i.e. 7 days after the 2nd infusion of ibalizumab).
Maltese: Individwu wieħed minn 153 ġie rrappurtat li kellu sensittività eċċessiva (reazzjoni allerġika) filJum 21 (jiġifieri 7 ijiem wara t-tieni infużjoni ta' ibalizumab).
English: Trogarzo is used in combination with other medicines called ‘antiretrovirals'.
Maltese: Trogarzo jintuża flimkien ma' mediċini oħrajn imsejħa “antiretrovirali”.
English: What Trogarzo contains - The active substance is ibalizumab.
Maltese: X'fih Trogarzo - Is-sustanza attiva hija ibalizumab.
English: The safety and efficacy of ibalizumab in children under the age of 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' ibalizumab fit-tfal taħt l-età ta' 18 ‑il sena għadhom ma ġewx determinati.
English: * Frequency was calculated based on 24 weeks of safety data from 153 subjects enrolled in Phase 2b study TMB-202 (n = 113) and Phase 3 study TMB-301 (n=40), as well as on at least 48 weeks of safety data from 27 subjects from TMB-301 that rolled-over into expanded access study TMB-311.
Maltese: Fażi 2b TMB-202 (n = 113) u l-istudju tal-Fażi 3 TMB-301 (n = 40), kif ukoll fuq mill-inqas 48 ġimgħa ta' data dwar issigurtà minn 27 individwu minn TMB-301 li komplew fuq l-istudju ta' aċċess estiż TMB-311.
English: Skin and subcutaneous tissue disorders rash**, dermatitis, dry skin
Maltese: taħt il-ġilda raxx**, dermatite, ġilda xotta
English: For instructions on dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal struzzjonijiet dwar id-dilwizzjoni tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.
English: This subject had 8 adverse reactions of rash, including 1 event of macular rash, 1 event of generalized rash and 6 events of maculo-papular rash at different times during treatment with ibalizumab.
Maltese: Dan l-individwu kellu 8 reazzjonijiet avversi ta' raxx, inkluż avveniment wieħed ta' raxx makulari, avveniment wieħed ta' raxx ġeneralizzat u 6 avvenimenti ta' raxx makulopapulari fi żminijiet differenti waqt il-kura b'ibalizumab.
English: Dizziness, nausea, fatigue and headache have been reported during treatment with ibalizumab (see section 4.8).
Maltese: nawżja, għeja u wġigħ ta' ras waqt il-kura b'ibalizumab (ara sezzjoni 4.8).
English: Ibalizumab is administered intravenously (IV), after diluting the appropriate number of vials in 250 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
Maltese: Ibalizumab jingħata ġol-vini (IV), wara li jiġi dilwit in-numru xieraq ta' kunjetti f'250 mL ta' sodium chloride 9 mg/mL (0.9 %) soluzzjoni għall-injezzjoni.
English: (≥1/10); common (≥1/100 to < 1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000);
Maltese: Il-frekwenzi huma definiti bħala komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000) u mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: By Week 16, i.e. prior to the possible switching of patients in the Placebo arm to the 15 mg/kg dose of ibalizumab every 2 weeks and/or to change in OBR for all patients, mean viral load decrease was 1.07 log10 copies/mL in Arm A, 1.33 log10 copies/mL in Arm B and 0.26 log10 copies/mL in the Placebo arm (p=0.002 vs Arm A, p<0.001 vs Arm B).
Maltese: Sal-Ġimgħa 16, jiġifieri qabel il-qlib possibbli tal-pazjenti fil-fergħa tal-Placebo għal doża ta' 15 mg/kg ta' ibalizumab kull ġimagħtejn u/jew għal bidla fl-OBR għall-pazjenti kollha, it-tnaqqis medju fit-tagħbija virali kien ta' 1.07 log10 kopji/mL fil-Fergħa A, 1.33 log10 kopji/mL fil-Fergħa B u
English: The trial was composed of three discrete periods:
Maltese: Il-prova kienet magħmula minn tliet perjodi diskreti:
English: Decreased susceptibility to ibalizumab, as defined by a decrease in Maximum Percent Inhibition (MPI), has been observed in most subjects experiencing virologic failure and may be associated with genotypic changes in the HIV-1 envelope coding sequence that results in the loss of potential N-linked glycosylation sites (PNGS) in the V5 loop of gp120.
Maltese: Ġiet osservata suxxettibilità mnaqqsa għal ibalizumab, kif definita minn tnaqqis fl-Inibizzjoni Perċentwali Massima (MPI), fil-biċċa l-kbira tal-individwi li jesperjenzaw falliment viroloġiku u tista' tiġi assoċjata ma' bidliet ġenotipiċi fis-sekwenza ta' kodifikazzjoni tal-pakkett tal-HIV-1 li tirriżulta f'telf ta' siti potenzjali tal-glukosilazzjoni marbuta ma' N (PNGS) fiċ-ċirku V5 ta' gp120.
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (cART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Maltese: F'pazjenti infettati bl-HIV b'defiċjenza immunitarja severa meta tinbeda t-terapija antiretrovirali kombinata (cART), tista' tirriżulta reazzjoni infjammatorja għal patoġeni asintomatiċi jew opportunistiċi residwali u tikkawża kundizzjonijiet kliniċi serji, jew aggravar tas-sintomi.
English: Gastrointestinal disorders diarrhoea, nausea, vomiting
Maltese: Disturbi gastro-intestinali dijarea, nawżja, rimettar
English: Pharmacotherapeutic group: Antivirals for systemic use, other antivirals.
Maltese: Antivirali għall-użu sistematiku, antivirali oħrajn.
English: Phase 3 trial TMB-301 was a single arm, multicenter clinical trial conducted in 40 heavily treatment-experienced HIV-infected subjects with multidrug resistant HIV-1.
Maltese: Il-prova tal-Fażi 3 TMB-301 kienet prova klinika ta' fergħa waħda, multiċentrika li saret f'40 individwu infettati bl-HIV li esperjenzaw kura qawwija b'HIV-1 reżistenti għal ħafna mediċini.
English: How to store Trogarzo
Maltese: Kemm ser tingħata Trogarzo
English: Phenotypic and genotypic test results revealed no evidence of cross-resistance between ibalizumab and any of the approved classes of anti-retroviral medicinal products.
Maltese: Ir-riżultati ta' testijiet fenotipiċi u ġenotipiċi ma żvelaw l-ebda evidenza ta' reżistenza inkroċjata bejn ibalizumab u kwalunkwe waħda mill-klassijiet approvati ta' prodotti mediċinali antiretrovirali approvati.
English: Nervous system disorders dizziness, headache, paraesthesia
Maltese: Disturbi fis-sistema nervuża sturdament, uġigħ ta' ras, paresteżija
English: • Insert sterile syringe needle into the vial through the center of the stopper and withdraw 1.33 mL from each vial (NOTE: a small residual amount may remain in the vial, discard unused portion) and transfer into a 250 mL intravenous bag of sodium chloride 9 mg/mL (0.9%) solution for injection.
Maltese: • Daħħal il-labra tas-siringa sterili ġol-kunjett min-nofs tat-tapp u iġbed 1.33 mL minn kull kunjett (NOTA: jista' jibqa' ammont residwali żgħir fil-kunjett, armi kwalunkwe porzjon li ma jkunx intuża) u ttrasferixxi f'borża li tingħata ġol-vina ta' 250 mL ta' sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni.
English: Common papule, pruritus, erythema nodosum
Maltese: Komuni papule, prurite, eritema nodusum
English: The subject received ibalizumab therapy for an additional 1.5 years before discontinuing voluntarily with an undetectable viral load (<50 copies/mL).
Maltese: L-individwu rċieva terapija b'ibalizumab għal sena u nofs oħra qabel ma waqaf volontarjament b'tagħbija virali mhux identifikabbli (< 50 kopja/mL).
English: Trogarzo has a low sodium content
Maltese: Trogarzo għandu kontenut baxx ta' sodium
English: Injury, poisoning and procedural complications contusion
Maltese: Korriment, avvelenament u komplikazzjonijiet proċedurali kontużjoni
English: If not administered immediately, store the diluted ibalizumab solution below 25°C for up to 4 hours, or in a refrigerator (2°C to 8°C) for up to 24 hours.
Maltese: Jekk ma tingħatax minnufih, aħżen is-soluzzjoni dilwita ta' ibalizumab taħt 25°C sa 4 sigħat, jew fi friġġ (2°C sa 8°C) sa 24 siegħa.
English: Diluted solution
Maltese: MANIFATTUR RESPONSABBLI
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti perjodiċi aġġornati dwar is-sigurtà Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà (PSURs) għal dan il prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Ibalizumab administered as a single agent exhibits nonlinear pharmacokinetics at a dose range of 0.3-25 mg/kg.
Maltese: Ibalizumab mogħti bħala aġent uniku juri farmakokinetika mhux lineari f'medda ta' doża ta' 0.3-25 mg/kg.
English: If refrigerated, allow the diluted ibalizumab solution to stand at room temperature (20°C to 25°C) for at least 30 minutes but no more than 4 hours prior to administration.
Maltese: Jekk titpoġġa fil-friġġ, ħalli s-soluzzjoni dilwita ta' ibalizumab toqgħod f'temperatura ambjentali (20°C sa 25°C) għal mill-inqas 30 minuta iżda mhux aktar minn 4 sigħat qabel l-għoti.
English: Ibalizumab was administered to pregnant females at a 110mg/kg weekly dose from gestation Day 20-22 until parturition (approximately 22 doses/animal).
Maltese: Ibalizumab ingħata lil nisa tqal f'doża ta' 110 mg/kg fil-ġimgħa minn Jum it-tqala 20-22 sal-ħlas (madwar 22 doża/annimal).
English: The primary efficacy endpoint was the proportion of subjects achieving a ≥ 0.5 log10 decrease in viral load from the beginning to the end of the “Functional monotherapy period” as compared to the proportion of subjects achieving a ≥ 0.5 log10 decrease from the beginning to the end of the “Control period”, as defined above.
Maltese: Proporzjon ta' individwi li kisbu tnaqqis ta' ≥ 0.5 log10 fit-tagħbija virali fi tmiem il perjodi ta' kontroll u ta' monoterapija funzjonali Proporzjon ta' individwi li kisbu tnaqqis ta'
English: Trogarzo contains less than 1 mmol sodium (23 mg) in each dose and therefore is essentially sodium-free.
Maltese: Trogarzo fih inqas minn 1 mmol ta' sodium (23 mg) f'kull doża u għalhekk huwa essenzjalment mingħajr sodium.
English: What Trogarzo is
Maltese: X'inhu Trogarzo
English: • Control period (Day 0 to Day 6): Subjects were either monitored on their current failing therapy or received no therapy if they had failed and discontinued treatment within the 8 weeks preceding screening.
Maltese: • Perjodu ta' kontroll (Jum 0 sa Jum 6): L-individwi ġew jew immonitorjati fuq it-terapija attwali tagħhom li ma kinitx qed taħdem jew ma rċevew l-ebda terapija jekk ma kinitx qiegħda taħdem u waqqfu l-kura fi żmien it-8 ġimgħat ta' qabel l-iskrinjar.
English: - One vial contains 200 mg of ibalizumab in 1.33 mL of solution.
Maltese: - Kunjett wieħed fih 200 mg ta' ibalizumab f'1.33 mL ta' soluzzjoni.
English: Tabulated list of adverse reactions
Maltese: Deskrizzjoni tar-reazzjonijiet avversi magħżula
English: How you will be given Trogarzo The drip (infusion) will be given into a vein over 15 to 30 minutes.
Maltese: Id-dripp (l-infużjoni) ser jingħata ġol-vina għal 15 sa 30 minuta.
English: This is a type of protein called a ‘monoclonal antibody' that can attach to a specific target in the body.
Maltese: Din hija tip ta' proteina msejħa “antikorp monoklonali” li tista' teħel ma' mira speċifika fil-ġisem.
English: There are no data on the effects of ibalizumab on human fertility.
Maltese: Fertilità M'hemmx data dwar l-effetti ta' ibalizumab fuq il-fertilità tal-bniedem.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (Contains 2 vials of 200 mg)
Maltese: KARTUNA (Fiha 2 kunjetti ta' 200 mg)
English: Renal impairment is not anticipated to impact the pharmacokinetics of ibalizumab.
Maltese: Individwu wieħed biss instab li kellu antikorpi kontra ibalizumab.
English: Following the recommended dose regimen (a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every 2 weeks), ibalizumab concentrations reached steady-state levels after the first 800 mg maintenance dose with mean trough concentrations over 30 µg/mL throughout the dosing interval.
Maltese: Wara l-kors ta' doża rakkomandat (doża tal-bidu waħda ta' 2,000 mg segwita minn doża ta' manteniment ta' 800 mg kull ġimagħtejn), il-konċentrazzjonijiet ta' ibalizumab laħqu livelli fi stat fiss wara l-ewwel doża ta' manteniment ta' 800 mg b'konċentrazzjonijiet minimi medji ta' aktar minn 30 µg/mL tul l-intervall tad-dożaġġ.
English: ** p < 0.0001 based on McNemar's test comparing the proportion of subjects achieving ≥ 0.5 log10 decrease in viral load at the end of the control and functional monotherapy periods.
Maltese: *intervall eżatt ta' fiduċja ta' 95 % ** p < 0.0001 abbażi tat-test McNemar li jqabbel il-proporzjon ta' individwi li kisbu tnaqqis ta' ≥ 0.5 log10 fit-tagħbija virali fi tmiem il-perjodi ta' kontroll u ta' monoterapija funzjonali.
English: • Remove the flip-off cap from the vial and wipe with an alcohol swab.
Maltese: • Neħħi l-għatu tat-tip flip-off mill-kunjett u imsaħ bi swab tal-alkoħol.
English: Trogarzo will be added to a drip (infusion bag) containing a sodium chloride (saline) solution before use.
Maltese: Trogarzo ser jiżdied ma' dripp (borża tal-infużjoni) li jkun fih soluzzjoni ta' sodium chloride (salina)
English: Based on the mechanism of action and target-mediated drug disposition of ibalizumab, it is not expected that ibalizumab will have pharmacokinetic drug-drug interactions with other medicinal products.
Maltese: mediċini bil-medjazzjoni fil-mira ta' ibalizumab, mhuwiex mistenni li ibalizumab ikollu interazzjonijiet mediċinali farmakokinetiċi ma' prodotti mediċinali oħrajn.
English: Ibalizumab blocks HIV-1 from infecting CD4+ T cells by binding to domain 2 of CD4 and interfering with the post-attachment steps required for the entry of HIV-1 virus particles into host cells and preventing the viral transmission that occurs via cell-cell fusion.
Maltese: billi jorbot mad-dominju 2 tas-CD4 u jinterferixxi mal-passi ta' wara r-rabta meħtieġa għad-dħul tal partiċelli tal-virus tal-HIV-1 f'ċelloli ospitanti u jipprevjeni t-trażmissjoni virali li sseħħ permezz talfużjoni bejn ċellola u oħra.
English: The safety and efficacy of ibalizumab in geriatric patients (≥ 65 years of age) have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' ibalizumab f'pazjenti ġerjatriċi (età ta' ≥ 65 sena) ma ġewx determinati.
English: All 153 subjects enrolled in Phase 2b and 3 clinical trials were tested for the presence of anti-ibalizumab IgG antibodies throughout their participation.
Maltese: Il-153 individwu kollha rreġistrati fil-provi kliniċi ta' Fażi 2b u 3 ġew ittestjati għall-preżenza ta' antikorpi
English: Decreased susceptibility to ibalizumab was a finding in the majority of patients who experienced virologic failure up to week 24 in the pivotal study.
Maltese: Issuxxettibilità mnaqqsa għal ibalizumab kienet sejba fil-maġġoranza tal-pazjenti li esperjenzaw falliment viroloġiku sal-ġimgħa 24 fl-istudju pivotali.
English: Specific metabolism studies were not conducted because ibalizumab is a protein.
Maltese: L-istudji speċifiċi dwar il-metaboliżmu ma sarux minħabba li ibalizumab huwa proteina.
English: Fifty-five percent of subjects had a ≥ 1 log10 reduction in viral load, and 48% of subjects had a ≥
Maltese: Ħamsa u ħamsin fil-mija tal-individwi kellhom tnaqqis ta' ≥ 1 log10 fit-tagħbija virali, u 48 % talindividwi kellhom tnaqqis ta' ≥ 2 log10 fit-tagħbija virali fil-Ġimgħa 25.
English: * The OSS indicates the number of fully active drugs in a subject's Optimized Background Regimen (OBR) based on both current and available historical resistance test results.
Maltese: * L-OSS jindika n-numru ta' mediċini kompletament attivi fil-Kors ta' Sfond Ottimizzat (OBR) ta' individwu, ibbażat kemm fuq ir-riżultati ta' test ta' reżistenza storika attwali kif ukoll disponibbli.
English: End of control period End of functional monotherapy period
Maltese: Tmiem il-perjodu ta' kontroll Tmiem il-perjodu ta' monoterapija funzjonali
English: Subjects with baseline CD4 counts < 50 cells/mm3 were less likely to achieve a HIV-1 RNA of < 200 copies/mL (or < 50 copies/mL) than subjects with > 50 cells/mm3.
Maltese: < 50 kopja/mL) minn individwi b'> 50 ċellola/mm3.
English: NAME OF THE MEDICINAL PRODUCT Trogarzo 200 mg concentrate for solution for infusion ibalizumab
Maltese: Informazzjoni għall-pazjent Trogarzo 200 mg konċentrat għal soluzzjoni għall-infużjoni ibalizumab
English: The HIV virus infects cells in your blood called ‘CD4' or ‘T-cells'.
Maltese: Il-virus tal-HIV jinfetta ċ-ċelloli fid-demm tiegħek imsejħa “CD4” jew “ċelloli T”.
English: Method of administration
Maltese: Reżistenza
English: This epitope is positioned on the surface of CD4 opposite to the site in domain 1 that is required for CD4 binding of the MHC class II molecules and, therefore, does not interfere with CD4-mediated immune functions.
Maltese: II tal-MHC u, għalhekk, ma jinterferixxix ma' funzjonijiet immunitarji mmedjati mis-CD4.
English: Date of first authorisation: {DD month YYYY}
Maltese: Data tal-ewwel awtorizzazzjoni: {JJ xahar SSSS}
English: 2 mL vial (Type I borosilicate glass) sealed with a stopper (butyl rubber) and an aluminum crimp cap.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Kunjett ta' 2 mL (ħġieġ borosilikat tat-Tip I) issiġillat b'tapp (gomma tal-butil) u għatu mitjun tal aluminju.
English: Trogarzo, in combination with other antiretroviral(s), is indicated for the treatment of adults infected with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive antiviral regimen (see section 5.1).
Maltese: Trogarzo, flimkien ma' antiretrovirali ieħor/oħrajn, huwa indikat għall-kura ta' adulti infettati blinfezzjoni tal-HIV-1 reżistenti għal ħafna mediċini li għalihom mhux possibbli li jinbena reġim antivirali soppressiv (ara sezzjoni 5.1).
English: Following administration of ibalizumab, at the clinically relevant dose rage of 800-2,000 mg, the maximum serum concentration (Cmax) increased dose proportionally, whereas the area under the concentration-time curve (AUC) increased in a greater than dose-proportional manner.
Maltese: Wara l-għoti ta' ibalizumab, fil-medda tad-doża klinikament rilevanti ta' 800-2,000 mg, il-konċentrazzjoni massima tas-seru (Cmax) żdiedet b'mod proporzjonali għad-doża, filwaqt li l-erja taħt il-kurva tal-ħin ta' konċentrazzjoni (AUC) żdiedet b'mod akbar minn dak proporzjonali għaddoża.
English: Missed dose
Maltese: Madankollu,
English: The recommended dose of ibalizumab is a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every 2 weeks.
Maltese: Id-doża rakkomandata ta' ibalizumab hija doża waħda tal-bidu ta' 2,000 mg segwita minn doża ta' manteniment ta' 800 mg kull ġimagħtejn.