FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Prac-tic 275 mg spot-on solution for medium dogs
Maltese: Prac-tic 275 mg soluzzjoni spot-on għall-klieb medji
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/066/001-012
Maltese: EU/2/06/066/001-012
English: Dosage Table The recommended minimum dose is 12.5 mg pyriprole per kg bodyweight, equivalent to 0.1 ml spoton solution per kg bodyweight.
Maltese: Id-doża minima rakkomandata hija ta' 12.5 mg pyriprole kull kg ta' piż korporali, ekwivalenti għal
English: Do not use in dogs less than 8 weeks of age or weighing less than 2 kg.
Maltese: Tużax fuq klieb li għandhom inqas minn 8 ġimgħat jew li jiżnu inqas minn 2 kg.
English: - neurological reactions: ataxia (lack of coordination) and convulsions.
Maltese: - reazzjonijiet newroloġiċi: atassja (nuqqas ta' koordinazzjoni) u konvulżjonijiet.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Maltese: jnaqqas l-effikaċja tal-prodott mediċinali veterinarju.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Prac-tic 137.5 mg
Maltese: PRAC-TIC 137.5 mg Pyriprole
English: PACKAGE LEAFLET: Prac-tic spot-on solution for dogs
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva
English: This veterinary medicinal product is for the treatment of ticks and adult fleas.
Maltese: Il-prodott mediċinali veterinarju huwa għat-trattament ta' qurdien u briegħed adulti.
English: EU/2/06/066/011 (6 pipettes)
Maltese: EU/2/06/066/011 (6 pipetti)
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinsab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/
English: EU/2/06/066/012 (30 pipettes)
Maltese: EU/2/06/066/012 (30 pipetta)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PIPETTE 275 mg
Maltese: JMISS MAL-PRODOTT BLISTER (275 mg)
English: Pyriprole kills ticks within 48 hours after application.
Maltese: Pyriprole joqtol il-qurdien fi żmien 48 siegħa wara l-applikazzjoni.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PIPETTE 625 mg
Maltese: JMISS MAL-PRODOTT BLISTER (625 mg)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Prac-tic 625 mg
Maltese: PRAC-TIC 625 mg Pyriprole
English: If you come into contact with the product, it may happen that your skin and mucosa become numb and irritated but these conditions usually disappear spontaneously.
Maltese: F'każ ta' kuntatt mal-prodott, tirżiħ u irritazzjoni tal-ġilda u tal-mukoża, li normalment jgħibu spontanjament meta jseħħu.
English: Pharmacotherapeutic group: Ectoparasiticides for topical use; ATCvet code: QP53AX26
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni spot-on għal applikazzjoni esterna fuq il-ġilda
English: Adult fleas are killed before they lay eggs for a minimum of 4 weeks after treatment.
Maltese: Il-briegħed adulti jiġu maqtula qabel ma jbidu mill-anqas 4 ġimgħat qabel it-trattament.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PIPETTE 137.5 mg
Maltese: JMISS MAL-PRODOTT BLISTER (137.5 mg)
English: Following treatment, ticks will detach from the host within 24 to 48 hours after infestation; however, single ticks might remain on the animal.
Maltese: Wara t-trattament, il-qurdien jinqalgħu minn mal-ospitu fi żmien 24 sa 48 siegħa wara infestazzjoni; madankollu jista' jibqa' xi qurdien waħdieni fuq l-annimal.
English: Following an overdose on a single occasion the following adverse effects were seen: vomiting, anorexia (loss of appetite), reduced body weight, muscle tremors, seizures, unsteadiness, laboured breathing.
Maltese: Wara doża eċċessiva f'okkażjoni ta' darba, ġew osservati l-effetti avversi li ġejjin: rimettar, anoressja (nuqqas ta' aptit), tnaqqis fil-piż korporali, tregħid fil-muskoli, aċċessjonijiet, nuqqas ta' sodizza, nifs batut.
English: TARGET SPECIES
Maltese: Doża unitarja
English: In dogs, adverse reactions are associated with neurological signs caused by metabolites of the active substance.
Maltese: Fil-klieb, reazzjonijiet avversi huma assoċjati ma' sinjali newroloġiċi kkaġunati minn metaboliti tas-sustanza attiva.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Prac-tic 137.5 mg spot-on solution for small dogs
Maltese: PRAC-TIC 137.5 mg soluzzjoni spot-on għal klieb żgħar
English: TARGET SPECIES Dog (>4.5-11 kg)
Maltese: SPEĊI GĦAL XIEX HUWA INDIKAT IL-PRODOTT Kelb (>4.5-11 kg)
English: EU/2/06/066/008 (6 pipettes)
Maltese: EU/2/06/066/008 (6 pipetti)
English: Parasites are killed through contact rather than by systemic exposure.
Maltese: Il-parasiti huma maqtula permezz tal-kuntatt aktar milli minn esponiment sistemiku.
English: Excipients:
Maltese: U KWANTITATTIVA
English: EU/2/06/066/009 (30 pipettes)
Maltese: EU/2/06/066/009 (30 pipetta)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Prac-tic 275 mg
Maltese: PRAC-TIC 275 mg Pyriprole
English: EU/2/06/066/002 (6 pipettes)
Maltese: EU/2/06/066/002 (6 pipetti)
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS One ml contains 125 mg pyriprole as a colourless to yellow, clear solution for external application to the skin.
Maltese: OĦRA ml fih 125 mg pyriprole bħala soluzzjoni ċara ta' mingħajr kulur li tkanġi fl-isfar għal applikazzjoni esterna fuq il-ġilda.
English: EU/2/06/066/005 (6 pipettes)
Maltese: EU/2/06/066/005 (6 pipetti)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Prac-tic 56.25 mg spot-on solution for very small dogs
Maltese: PRAC-TIC 56.25 mg soluzzjoni spot-on għal klieb żgħar ħafna
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Prac-tic spot-on for dogs
Maltese: Dan il-prodott mediċinali veterinarju qiegħed biss għal applikazzjoni spot-on.
English: Unit dose Pyriprole
Maltese: Prac-tic spot-on għall-klieb Pyriprole
English: EU/2/06/066/003 (30 pipettes)
Maltese: EU/2/06/066/003 (30 pipetta)
English: Pipette size to be used
Maltese: Uża l-kombinazzjoni xierqa ta' pipetti
English: EU/2/06/066/006 (30 pipettes)
Maltese: EU/2/06/066/006 (30 pipetta)
English: Since the veterinary medicinal product completely eliminates egg production, it breaks the flea life cycle.
Maltese: Il-prodott mediċinali veterinarju ġie speċifikament żviluppat għall-klieb.
English: It acts by interacting with ligand-gated chloride channels, in particular those gated by the neurotransmitter gammaaminobutyric acid (GABA), thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes.
Maltese: Huwa jaġixxi billi jkollu effett mal-ligand-gated chloride channels, partikolarment dawk imxattba bin-newrotrażmettitur gamma-aminobutyric acid (GABA), b'hekk jimblokka t-trasferiment ta' qabel u ta' wara s-sinapsi ta'
English: - application site and skin reactions: pruritus (itchy skin), hair change, dermatitis (inflammation of the skin), erythema (redness of skin), alopecia (loss of hair), fur discoloration and greasy appearance of hair.
Maltese: - reazzjonijiet fis-sit tal-applikazzjoni u fuq il-ġilda: prurite (ħakk fuq il-ġilda), tibdil fix-xagħar, dermatite (infjammazzjoni tal-ġilda), eritema (ħmura tal-ġilda), alopeċja (telf ta' xagħar), telf fil-kulur tal-fer u dehra maħmuġa tax-xagħar.
English: Snap-off the top of the pipette along the scored line.
Maltese: Kisser il-parti ta' fuq tal-parti li titqaċċat mal-linja mibruxa.
English: STATEMENT OF ACTIVE SUBSTANCES One pipette delivers: Unit dose Pyriprole 5.0 ml
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Kull pipetta tagħti:
English: On very rare occasions the following have been reported: - application site and skin reactions :pruritus (itchy skin), hair change, dermatitis (inflammation of the skin), erythema (redness of skin), alopecia (loss of hair), fur discoloration and greasy appearance of hair.
Maltese: F'okkażjonijiet rari ħafna, ġew irrapportati dawn li ġejjin: - reazzjonijiet fis-sit tal-applikazzjoni u fuq il-ġilda: prurite (ħakk fuq il-ġilda), tibdil fix-xagħar, dermatite (infjammazzjoni tal-ġilda), eritema (ħmura tal-ġilda), alopeċja (telf ta' xagħar), telf fil-kulur tal-fer u dehra maħmuġa tax-xagħar.
English: One treatment is effective against ticks for 4 weeks.
Maltese: Trattament wieħed għandu effikaċja għal tul ta' 4 ġimgħat.
English: Dosage Table
Maltese: TWISSIJIET SPEĊJALI
English: Efficacy against new infestations with fleas persists for a minimum of 4 weeks.
Maltese: L-effikaċja kontra infestazzjonijiet ġodda bil-briegħed tippersisti għal minimu ta' 4 ġimgħat.
English: EMEA/V/C/122
Maltese: EMEA/V/C/122 RAPPORT TA' VALUTAZZJONI
English: It is available in three pack sizes; 8.8, 17.5 and 35.1 ml bottles for dogs.
Maltese: Jinsab disponibbli fi tliet daqsijiet ta' pakketti; fi fliexken għall-klieb ta' 8.8ml, 17.5ml u 35.1ml.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) POSATEX
Maltese: PUBBLIKA EWROPEW (EPAR) POSATEX
English: Posatex contains three active substances: orbifloxacin, mometasone furoate monohydrate and posaconazole.
Maltese: Posatex fih tliet sustanzi attivi: orbifloxacin, mometasone furoate monohydrate u posaconzole.
English: Orbifloxacin is an antibiotic that belongs to the group fluoroquinolones.
Maltese: Orbifloxacin huwa antibijotiku li jappartjeni għall-grupp fluoroquinolones.
English: Posatex at the recommended dose and following 7 days of treatment was as effective as the comparator medicine in improving the symptoms (redness, swelling, ear discharge, discomfort) of ear infections in dogs with acute or recurrent bacterial or fungal infections.
Maltese: Fid-doża rakkomandata u wara 7 ijiem ta' trattament Posatex kien effikaċi daqs il-mediċina ta' tqabbil fit-titjib tas-sintomi (ħmura, nefħa, tnixxija mill-widna, sensazzjoni skomda) ta' linfezzjonijiet tal-widnejn fil-klieb b'infezzjonijiet batterjali jew tal-fungi akuti jew rikorrenti.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq iktar informazzjoni abbażi tar-rakkomandazzjonijiet tas-CVMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: Equal numbers of dogs were assigned to each group, of different breeds, ages, sex and weight.
Maltese: Ġie assenjat l-istess numru ta' klieb għal kull grupp ta' razza, età, sess u piż differenti.
English: What is Posatex?
Maltese: X'inhu Posatex?
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Posatex to S-P Veterinary, United Kingdom on 23/06/2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea għal Posatex lil S-P Veterinary, fir-Renju Unit fil-23/06/2008.
English: Mometasone furoate monohydrate is a steroid, which is a type of substance that helps to reduce inflammation.
Maltese: Mometasone furoate monohydrate huwa sterojdi li huwa tip ta' sustanza li tgħin fit-tnaqqis ta' l-infjammazzjoni.
English: Posaconazole is an antifungal that belongs to the group triazoles.
Maltese: Posaconazole hija sustanza kontra l-fungu li tappartjeni għall-grupp triazoles..
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Posatex exceed its risks for the treatment of acute otitis externa and acute exacerbations of recurrent otitis externa in dogs and recommended that Posatex be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Posatex jisbqu r-riskji tiegħu għat-trattament ta' otite esterna akuta u taħrix akut ta' otite esterna rikorrenti fil-klieb u irrakkomanda li Posatex jingħata awtorizzazzjoni biex jitqiegħed fis-suq.
English: What is the risk associated with Posatex?
Maltese: X'inhu r-riskju assoċjat ma' Posatex?
English: Why has Posatex been approved?
Maltese: Għaliex ġie approvat Posatex?
English: By blocking DNA gyrase, orbifloxacin prevents the bacteria from making DNA and stops them making proteins and growing, resulting in their death.
Maltese: Billi jimblokka id-DNA gyrase, orbifloxacin jipprevjeni lbatterja milli joħolqu d-DNA u jwaqqafhom milli joħolqu proteini u jikbru li b'hekk iwassal sabiex dawn imutu.
English: The benefit-risk balance may be found in module 6 of this EPAR.
Maltese: Il-bilanċ bejn ir-riskju u l-benefiċċju jinsab fil-modulu 6 ta' dan l-EPAR.
English: Other information about Posatex:
Maltese: Iktar tagħrif dwar Posatex:
English: How has Posatex been studied?
Maltese: Kif ġie studjat Posatex?
English: Two of the active substances in Posatex, orbifloxacin and posaconazole, work against the cause of the infection, while the third one, mometasone furoate monohydrate, works on the inflammation.
Maltese: Ta' spiss iwasslu sabiex il-widna tkun infjammata (ħamra, minfuħa u tqabbad il-ħakk) Tnejn missustanzi attivi f'Posatex, orbifloxacin u posaconazole jaħdmu kontra l-kawża ta' l-infezzzjoni waqt li t-tielet waħda, mometasone furoate monohydrate taħdem fuq l-infjammazzjoni.
English: How does Posatex work?
Maltese: Għal xiex jintuża Posatex?
English: In both studies the effectiveness of Posatex was compared with that of ear drops containing three similar active substances.
Maltese: Fiż-żewġ studji l-effikaċja ta' Postaex tqabblet ma' dik tat-taqtiriet tal-widnejn li kien fihom tliet sustanzi attivi li kienu simili.
English: For a full list of all side-effects reported with Posatex, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' l-effetti sekondarji kollha rrappurtati b'Posatex, ara l-Fuljett ta' Tagħrif.
English: It works by blocking an enzyme called ‘DNA gyrase', which is important in allowing bacteria to make copies of their DNA.
Maltese: Dan jaħdem billi jimblokka enżim imsejjaħ ‘DNA gyrase', li huwa importanti fil-fatt li jħalli l-batterja sabiex jagħmlu kopji tad-DNA tagħhom.
English: It works by preventing the formation of ergosterol, which is an important part of fungal cell walls.
Maltese: Din taħdem billi tipprevjeni l-iffurmar ta' ergosterol li huwa parti importanti millħitan taċ-ċelloli tal-fungi.
English: Posatex is an ear drop suspension, white to off white in colour.
Maltese: Saru żewġ studji kbar fuq il-post, wieħed fl-Ewropa u l-ieħor l-Amerka.
English: Trial TMB-301
Maltese: Prova TMB-301
English: Trial TNX-355.03
Maltese: Prova TNX-355.03
English: 10 vials (13.3 mL)
Maltese: 10 kunjetti (13.3 mL)
English: ATC code: J05AX23
Maltese: J05AX23
English: WuXi Biologics Co, Ltd 108 Meiliang Road, MaShan Binhu District, Wuxi, 214092, China
Maltese: WuXi Biologics Co, Ltd 108 Meiliang Road, MaShan Binhu District, Wuxi Jiangsu, 214092,
English: Ibalizumab is active against HIV-1 group M isolates (subtypes A, B, C, D, E, or O).
Maltese: Ibalizumab huwa attiv kontra l-iżolati ta' grupp M tal-HIV-1 (sottotipi A, B, C, D, E, jew O).
English: Adverse reaction frequency*
Maltese: Reazzjoni avversa frekwenza*
English: HIV-RNA (copies/mL)
Maltese: HIV-RNA (kopji/mL)
English: Pack of 2 vials.
Maltese: Pakkett ta' 2 kunjetti.
English: Marketing Authorisation Holder and manufacturer Theratechnologies International Limited 10 Earlsfort Terrace,
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-manifattur Theratechnologies International Limited 10 Earlsfort Terrace,
English: Cardiac disorders ventricular extrasystoles, electrocardiogram abnormal
Maltese: Disturbi kardijaċi extrasystoles ventrikulari, elettrokardjogramma anormali
English: Maintenance dose of 800 mg
Maltese: manteniment ta' 800 mg.
English: A tabulated list of adverse reactions is presented in Table 1.
Maltese: Lista f'tabella ta' reazzjonijiet avversi hija ppreżentata f'Tabella 1.
English: The bioavailability is 100% by definition.
Maltese: Il-bijodisponibbiltà hija 100 % skont id-definizzjoni.
English: Allergic reaction (hypersensivity).
Maltese: • Reazzjoni allerġika (sensittività eċċessiva).
English: MIAS Pharma Limited Suite 2 Stafford House, Strand Road, Portmarnock, Co. Dublin, D13 H525 Ireland
Maltese: MIAS Pharma Limited Suite 2 Stafford House, Strand Road, Portmarnock, Co.
English: The most frequently reported adverse reactions were rash (9.2%), diarrhoea (3.9%), dizziness (3.9%), headache (3.9%), nausea (3.9%), fatigue (2.0%) and vomiting (2.0%).
Maltese: (3.9 %), uġigħ ta' ras (3.9 %), nawżja (3.9 %), għeja (2.0 %) u rimettar (2.0 %).
English: Ibalizumab, a humanized monoclonal antibody of immunoglobulin G type 4 (IgG4), is a CD4 domain 2-directed HIV-1 inhibitor.
Maltese: Ibalizumab, antikorp monoklonali umanizzat tal-immunoglobulina G tip 4 (IgG4), huwa inibitur talHIV-1 dirett mid-dominju 2 ta' CD4.
English: Ibalizumab dose
Maltese: ibalizumab.
English: Theratechnologies International Limited 10 Earlsfort Terrace, Dublin 2, D02 T380
Maltese: Theratechnologies Limited 10 Earlsfort Terrace Dublin 2, D02 T380, L-Irlanda L-Irlanda
English: At Baseline, median [Min - Max] viral load and CD4+ T cell counts were 35,350 [304 - 743,000] copies/mL and 73 [0 - 676] cells/mm3, respectively.
Maltese: Fil-Linja bażi, it-tagħbija virali medjana [MinMass] u l-għadd ta' ċelloli CD4+ T kienu ta' 35,350 [304 - 743,000] kopja/mL u 73 [0 - 676] ċellola/mm3, rispettivament.
English: Dublin 2, D02 T380, Ireland Tel: + 35319201427 regulatoryaffairs@theratech.com
Maltese: Earlsfort Terrace, Dublin 2, D02 T380, L-Irlanda Tel: + 35319201427 regulatoryaffairs@theratech.com
English: Immune reconstitution inflammatory syndrome (IRIS)
Maltese: Sindrome infjammatorju ta' rikostituzzjoni immunitarja (IRIS)
English: Final report submission: 31Oct-2025
Maltese: 31Ott-2025
English: It is also active against HIV-1 resistant to currently approved antiretroviral medicinal products and exhibits antiretroviral activity against R5-tropic, X4-tropic, and dual-tropic HIV-1.
Maltese: Huwa wkoll attiv kontra l-HIV-1 reżistenti għall-prodotti mediċinali antiretrovirali li huma approvati bħalissa u juri attività antiretrovirali kontra R5-tropic, X4-tropic, u HIV-1 dual tropic.
English: The majority of subjects in Trial TMB-301 were male (85%), white (55%) and between 23 and 65 years of age (mean [SD] age: 50.5 [11.0] years).
Maltese: Il-maġġoranza tal-individwi fil-Prova TMB-301 kienu rġiel (85 %), bojod (55 %) u ta' età bejn 23 u 65 sena (età medja [SD]: 50.5 snin/ [11.0]-il sena).
English: Transmission of HIV
Maltese: Trażmissjoni tal-HIV
English: Virologic response CD4 cell counts (cells/ mm3)
Maltese: Rispons viroloġiku Għadd ta' ċelloli CD4 (ċelloli/ mm3)
English: - The other excipients are sucrose, sodium chloride (see section 2 ‘Trogarzo has a low sodium content'), polysorbate 80, histidine, hydrochloric acid, water for injections.
Maltese: - L-eċċipjenti l-oħrajn huma sucrose, sodium chloride (ara sezzjoni 2 “Trogarzo għandu kontenut baxx ta' sodium”), polysorbate 80, histidine, hydrochloric acid, ilma għall-injezzjonijiet.
English: How to store Trogarzo 6.
Maltese: Kif taħżen Trogarzo 6.
English: Vascular disorders hypertension, labile hypertension, orthostatic hypotension
Maltese: Disturbi vaskulari ipertensjoni, ipertensjoni labili, ipotensjoni ortostatika
English: **Includes pooled terms “rash”, “rash erythematous”, “rash generalized”, “rash macular”, “rash maculopapular”, “rash pruritic” and “rash papular”.
Maltese: **Jinkludi termini miġbura “raxx”, “raxx eritematuż”, “raxx ġeneralizzat”, “raxx makulari”, “raxx makulopapulari”, “raxx pruritiku” u “raxx papulari”.
English: The median time to maximum serum concentration (Tmax) of 2,000 mg and 800 mg is 1 hr and 10 min, respectively.
Maltese: Iż-żmien medjan għall-konċentrazzjoni massima fis-seru (Tmax) ta' 2,000 mg u 800 mg huwa siegħa u 10 min, rispettivament.
English: {DD month YYYY}
Maltese: {JJ xahar SSSS}
English: Trogarzo contains the active substance ibalizumab.
Maltese: Trogarzo fih is-sustanza attiva ibalizumab.
English: This behaviour is characteristic of saturable (capacity-limited) elimination kinetics.
Maltese: Din l-imġiba hija karatteristika ta' kinetika ta' eliminazzjoni saturata (limitata mill-kapaċità).
English: The subjects were heavily treatment-experienced: 53% of participants had been treated with 10 or more antiretroviral drugs prior to trial enrolment; 98% percent had been treated with NRTIs, 98% with PIs, 80% with NNRTIs, 78% with INSTIs, 30% with gp41 fusion inhibitors, and 20% with CCR5 coreceptor antagonists.
Maltese: L-individwi esperjenzaw kura qawwija: 53 % tal-parteċipanti kienu ġew ikkurati b'10 mediċini antiretrovirali jew aktar qabel ir-reġistrazzjoni fil-prova; 98 % fil-mija kienu ġew ikkurati b'NRTIs, 98 % b'PIs, 80 % b'NNRTIs, 78 % b'INSTIs, 30 % b'inibituri ta' fużjoni gp41,
English: Results are similar to the adult population (≥18 to 65 years of age), however no definite conclusions can be drawn.
Maltese: Ir riżultati huma simili għall-popolazzjoni adulta (≥età ta' 18 sa 65 sena), madankollu ma jistgħux jintlaħqu konklużjonijiet definittivi.
English: • Functional monotherapy period (Day 7 to Day 13): All subjects received a 2,000 mg loading dose of ibalizumab on Day 7.
Maltese: • Perjodu ta' monoterapija funzjonali (Jum 7 sa Jum 13): L-individwi kollha rċevew doża tal bidu ta' ibalizumab ta' 2,000 mg fil-Jum 7.
English: Ibalizumab pharmacokinetics in geriatric patients (≥ 65 years of age) is limited (n = 5).
Maltese: Popolazzjoni tal-anzjani Il-farmakokinetika ta' ibalizumab fil-pazjenti ġerijatriċi (età ta' ≥65 sena) hija limitata (n = 5).
English: No. of subjects achieving <200 HIV-1 RNA copies/mL (n/N)
Maltese: Nru ta' individwi li kisbu <200 HIV-1 RNA kopja/mL (n/N)
English: Hydrochloric acid Water for injections
Maltese: Hydrochloric acid Ilma għall-injezzjonijiet
English: No. of subjects achieving <50 HIV-1 RNA copies/mL (n/N)
Maltese: Nru ta' individwi li kisbu <50 HIV-1 RNA kopja/mL (n/N)
English: The use of an investigational drug as a component of the optimized background regimen was allowed.
Maltese: L-użu ta' mediċina investigattiva bħala komponent tal-kors ta' sfond ottimizzat kien permess.
English: Loading dose of 2,000 mg
Maltese: Doża tal-bidu ta' 2,000 mg
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and pneumocystis jiroveci pneumonia.
Maltese: Eżempji rilevanti huma retinite taċ-ċitomegalovirus, infezzjonijiet mikobatteriċi ġeneralizzati u/jew fokali, u pulmonite pneumocystis jiroveci.
English: At Week 2, the mean viral load decrease was 0.87 log10 copies/mL in Arm A, 1.15 log10 copies/mL in Arm B and 0.38 log10 copies/mL in the Placebo arm (p=0.003 vs Arm A, p<0.001 vs Arm B).
Maltese: Fit-Tieni Ġimgħa, it-tnaqqis medju fit-tagħbija virali kien ta' 0.87 log10 kopji/mL fil-Fergħa A, 1.15 log10 kopji/mL fil-Fergħa B u 0.38 log10 kopji/mL fil-fergħa tal-Plaċebo (p=0.003 kontra Fergħa A, p<0.001 kontra Fergħa B).
English: Each vial contains 200 mg of ibalizumab (in 1.33 mL of solution).
Maltese: Kull kunjett fih 200 mg ta' ibalizumab (f'1.33 mL ta' soluzzjoni).
English: Following single-dose administrations of 10 and 25 mg/kg of ibalizumab, clearance is 0.5 to 0.36 mL/h/kg and elimination half-life is 37.8 and 64.1 hours, respectively.
Maltese: Wara għoti b'doża waħda ta' 10 u 25 mg/kg ta' ibalizumab, it-tneħħija hija ta' 0.5 sa 0.36 mL/h/kg u n-nofs ħajja ta' eliminazzjoni hija ta' 37.8 u 64.1 sigħat, rispettivament.
English: A population pharmacokinetic analysis was performed to explore the potential effects of selected covariates (age, body weight, sex, baseline CD4+ cell count) on ibalizumab pharmacokinetics.
Maltese: Saret analiżi farmakokinetika tal-popolazzjoni biex jiġu esplorati l-effetti potenzjali ta' kovarjati magħżula (età, piż tal-ġisem, sess, għadd ta' ċelloli CD4+ fil-linja bażi) fuq il-farmakokinetika ta'
English: abnormal results on tests of the heart's electrical activity (electrocardiogram)
Maltese: • riżultati anormali fit-testijiet tal-attività elettrika tal-qalb (elettrokardjogramma)