FrancophonIA/ELRC3.0 huggingface dataset:
English: Out of the 153 subjects in Phase 2b and 3 clinical studies, one subject experienced a severe rash (non-serious).
Slovenian: Izmed 153 preiskovancev v 2.b in 3. fazi kliničnih študij je en preiskovanec imel hud kožni izpuščaj (ki ni bil resen).
English: What Trogarzo looks like and contents of the pack Trogarzo is a colourless to slightly yellow, clear to slightly opalescent concentrate for solution for infusion (sterile concentrate), with no visible particles.
Slovenian: Zdravilo Trogarzo je brezbarven do rahlo rumen, bister do rahlo opalescenten koncentrat za raztopino za infundiranje (sterilen koncentrat) brez vidnih delcev.
English: Ibalizumab administered as a single agent exhibits nonlinear pharmacokinetics at a dose range of 0.3-25 mg/kg.
Slovenian: Ibalizumab, uporabljen kot samostojno zdravilo, kaže nelinearno farmakokinetiko v razponu odmerkov 0,3-25 mg/kg.
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.
Slovenian: Izmed 153 preiskovancev se je pri dveh preiskovancih razvil vnetni sindrom imunske obnove (VSIO; glejte poglavje 4.4), ki se je pokazal kot eksacerbacija progresivne multifokalne levkoencefalopatije (resne) in kot eksacerbacija kriptokokne kožne infekcije (resne).
English: Trogarzo is used in combination with other medicines called ‘antiretrovirals'.
Slovenian: Zdravilo Trogarzo se uporablja v kombinaciji z drugimi zdravili, imenovanimi „protiretrovirusna zdravila“.
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%).
Slovenian: (3,9 %), glavobol (3,9 %), navzea (3,9 %), utrujenost (2,0 %) in bruhanje (2,0 %).
English: Proportion of subjects achieving a ≥ 0.5 log10
Slovenian: Delež preiskovancev, ki so dosegli zmanjšanje virusne obremenitve za ≥ 0,5 log10
English: Immune reconstitution inflammatory syndrome (IRIS)
Slovenian: Vnetni sindrom imunske obnove (VSIO)
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.
Slovenian: Ibalizumab preprečuje, da bi virus HIV-1 okužil celice CD4+ T, tako da se veže na domeno 2 CD4 in ovira korake po pritrditvi, ki so potrebni za vstop delcev virusa HIV-1 v gostiteljske celice, in preprečuje prenos virusa prek fuzije celic.
English: There are no data from the use of ibalizumab in pregnant women.
Slovenian: Podatkov o uporabi ibalizumaba pri nosečnicah ni.
English: Ibalizumab is not recommended during pregnancy.
Slovenian: Ibalizumab v nosečnosti ni priporočljiv.
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.
Slovenian: Pri večini preiskovancev, pri katerih je prišlo do virološkega neuspeha, so opažali zmanjšano dovzetnost za ibalizumab, ki je opredeljena kot zmanjšanje največjega deleža inhibicije (Maximum Percent Inhibition - MPI) in je lahko povezana z genotipskimi spremembami v sekvenci, ki kodira ovojnico HIV-1, kar povzroči izgubo potencialnih N-glikozilacijskih mest (potential N-linked glycosylation sites - PNGS) v zanki V5 gp120.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: PROIZVAJALCI BIOLOŠKE UČINKOVINE IN PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Human immunoglobulin (IgG) is known to cross the placental barrier.
Slovenian: Znano je, da humani imunoglobulin (IgG) prehaja placentno pregrado.
English: Subjects were required to have a viral load greater than 1,000 copies/mL and documented resistance to at least one antiretroviral medication from three classes of antiretroviral medications as measured by resistance testing.
Slovenian: 1.000 kopij/ml in dokumentirano odpornost proti vsaj enemu protiretrovirusnemu zdravilu iz treh skupin protiretrovirusnih zdravil, izmerjeno s testiranjem odpornosti.
English: Trogarzo can cause serious side effects that you need to tell your doctor or nurse about straight away.
Slovenian: Bodite pozorni na neželene učinke Zdravilo Trogarzo lahko povzroči resne neželene učinke, o katerih morate nemudoma obvestiti zdravnika ali medicinsko sestro.
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.
Slovenian: Če ste zdravilo hranili v hladilniku, pustite razredčeno raztopino ibalizumaba na sobni temperaturi (20-25 °C) vsaj 30 minut, vendar ne več kot 4 ure, preden daste zdravilo.
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.
Slovenian: TMB-202 (n = 113) in 3. fazo študije TMB-301 (n = 40), ter vsaj 48 tednov varnostnih podatkov 27 preiskovancev iz študije TMB-301, ki so bili preusmerjeni v razširjeno študijo dostopa TMB-311.
English: After the infusion is complete, flush with 30 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
Slovenian: Po zaključku infuzije izperite s 30 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
English: Elderly population
Slovenian: Starejše osebe
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.
Slovenian: Če razredčene raztopine ibalizumaba ne daste takoj, jo hranite pri temperaturi do 25 °C do 4 ure ali v hladilniku (2-8 °C) do 24 ur.
English: Beginning at Day 21, an 800 mg maintenance dose of ibalizumab was administered every two weeks through Week 25.
Slovenian: Od 21. dne dalje se je vzdrževalni odmerek 800 mg ibalizumaba dajal vsaka dva tedna do 25. tedna.
English: Theratechnologies International Limited 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland Tel: + 35319201427 regulatoryaffairs@theratech.com
Slovenian: Theratechnologies International Limited 10 Earlsfort Terrace, Dublin 2, D02 T380, Irska Tel. št.: + 35319201427 regulatoryaffairs@theratech.com
English: • spots or swelling
Slovenian: • madeži ali otekanje
English: Trogarzo will be added to a drip (infusion bag) containing a sodium chloride (saline) solution before use.
Slovenian: Zdravilo Trogarzo se pred uporabo doda kapalni infuziji (infuzijski vrečki), ki vsebuje raztopino natrijevega klorida (fiziološka raztopina).
English: In order to further characterise the efficacy of ibalizumab in combination with other anti-retroviral medicinal products, 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, the MAH should conduct and submit the results of a study based on data from a product registry.
Slovenian: Študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PAES): Da bi dodatno opredelili učinkovitost ibalizumaba v kombinaciji z drugimi protiretrovirusnimi zdravili za zdravljenje odraslih, okuženih z virusom HIV-1, ki je odporen proti več zdravilom, in za katere zato ni mogoče zgraditi supresivnega protivirusnega režima, mora imetnik dovoljenja za promet z zdravilom izvesti in predložiti rezultate študije, ki temelji na podatkih iz registra zdravila.
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.
Slovenian: Po priporočeni shemi odmerjanja (enkratni polnilni odmerek 2.000 mg, ki mu je sledil vzdrževalni odmerek 800 mg vsaka 2 tedna) so koncentracije ibalizumaba dosegle stanje dinamičnega ravnovesja po prvem vzdrževalnem odmerku 800 mg s srednjo najnižjo koncentracijo nad 30 µg/ml med celotnim intervalom odmerjanja.
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.
Slovenian: Glede na mehanizem delovanja in ciljno usmerjeno porazdelitev ibalizumaba ni pričakovati, da bi ta imel medsebojne farmakokinetične interakcije z drugimi zdravili.
English: • Once diluted, the ibalizumab solution should be administered immediately.
Slovenian: • Ko je raztopina ibalizumaba razredčena, jo je treba takoj uporabiti.
English: **Includes pooled terms “rash”, “rash erythematous”, “rash generalized”, “rash macular”, “rash maculopapular”, “rash pruritic” and “rash papular”.
Slovenian: **Vključuje skupne izraze „izpuščaj“, „eritematozni izpuščaj“, „generaliziran izpuščaj“, „makularni izpuščaj“, „makulopapularni izpuščaj“, „pruritični izpuščaj“ in „papularni izpuščaj“.
English: Trogarzo contains less than 1 mmol sodium (23 mg) in each dose and therefore is essentially sodium-free.
Slovenian: Zdravilo Trogarzo vsebuje manj kot 1 mmol natrija (23 mg) v enem odmerku, kar v bistvu pomeni „brez natrija“.
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.
Slovenian: * natančen 95-% interval zaupanja ** p < 0,0001, ki temelji na McNemarjevem testu, ki primerja delež udeležencev, ki so dosegli zmanjšanje virusne obremenitve za ≥ 0,5 log10 ob koncu obdobij nadzorovanja in funkcionalne monoterapije.
English: Ibalizumab pharmacokinetics have not been evaluated in paediatric patients.
Slovenian: Farmakokinetika ibalizumaba pri pediatričnih bolnikih ni bila ocenjena.
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).
Slovenian: Opaženo je bilo zvišanje povprečnega števila T-celic CD4+ od izhodišča do 25. tedna za 62 celic/mm3 (analiza populacije z namenom zdravljenja (ITT)).
English: In order to avoid transmission of HIV to the infant it is recommended that HIV infected women do not breast-feed their infants under any circumstances.
Slovenian: Da bi se izognili prenosu virusa HIV na dojenčka, je priporočljivo, da ženske, okužene z virusom HIV,
English: As a result, ibalizumab was discontinued.
Slovenian: Zato je bila uporaba ibalizumaba prekinjena.
English: If no infusionassociated adverse reactions have occurred, the duration of the subsequent infusions (maintenance doses) can be decreased to no less than 15 minutes.
Slovenian: Če se neželeni učinki, povezani z infuzijo, niso pojavili, se lahko trajanje nadaljnjih infuzij (vzdrževalnih odmerkov) skrajša na ne manj kot 15 minut.
English: Store and transport refrigerated (2°C to 8°C).
Slovenian: Shranjujte in prevažajte v hladilniku (2-8 °C).
English: Other medicines and Trogarzo Tell your doctor if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Trogarzo in one or more subsets of the paediatric population in the treatment of HIV-1 infection (see section 4.2 for information on paediatric use).
Slovenian: Trogarzo za eno ali več podskupin pediatrične populacije pri zdravljenju okužbe z virusom HIV-1 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: 6.6 Special precautions for disposal and other handling This medicinal product should be inspected visually for particulate matter and discoloration prior to administration.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Pred uporabo je treba to zdravilo vizualno pregledati, da ne vsebuje trdih delcev in ni spremenjene barve.
English: Fifty-five percent of subjects had a ≥ 1 log10 reduction in viral load, and 48% of subjects had a ≥
Slovenian: Pri 55 % preiskovancev se je v 25. tednu virusna obremenitev zmanjšala za ≥ 1 log10, pri 48 %
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.
Slovenian: Vseh 153 preiskovancev, vključenih v 2.b in 3. fazo kliničnih preskušanj, je bilo v času njihovega sodelovanja v študiji testiranih na prisotnost protiteles proti IgG.
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).
Slovenian: 4.1 Terapevtske indikacije Zdravilo Trogarzo je v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje odraslih, okuženih z virusom HIV-1, odpornim proti več zdravilom, za katere sicer ni mogoče izdelati supresivnega protivirusnega režima (glejte poglavje 5.1).
English: Both subjects were discontinued from ibalizumab treatment.
Slovenian: Oba preiskovanca sta prekinila zdravljenje z ibalizumabom.
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).
Slovenian: Do 16. tedna, tj. pred možnim prehodom bolnikov iz skupine s placebom na odmerek 15 mg/kg ibalizumaba na vsaka 2 tedna in/ali spremembo OBR pri vseh bolnikih, je bilo povprečno zmanjšanje virusne obremenitve 1,07 log10 kopij/ml v skupini A, 1,33 log10 kopij/ml v skupini B in 0,26 log10 kopij/ml v skupini s placebom (p = 0,002 v primerjavi s skupino A, p < 0,001 v primerjavi s skupino B).
English: If a maintenance dose (800 mg) of ibalizumab is missed by 3 days or longer beyond the scheduled dosing day, a loading dose (2,000 mg) should be administered as early as possible.
Slovenian: Izpuščeni odmerek Če vzdrževalni odmerek (800 mg) ibalizumaba izpustimo za 3 dni ali več po predvidenem dnevu odmerjanja, je treba čim prej dati polnilni odmerek (2.000 mg).
English: - One vial contains 200 mg of ibalizumab in 1.33 mL of solution.
Slovenian: - Ena viala vsebuje 200 mg ibalizumaba v 1,33 ml raztopine.
English: How to store Trogarzo 6.
Slovenian: Shranjevanje zdravila Trogarzo 6.
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.
Slovenian: je bilo manj verjetno, da bi dosegle HIV-1 RNK < 200 kopij/ml (ali < 50 kopij/ml), kot pri preiskovancih z > 50 celic/mm3.
English: All patients must be observed during and for 1 hour after completion of ibalizumab administration for at least the first infusion.
Slovenian: Vse bolnike je treba vsaj ob prvi infuziji ibalizumaba opazovati med infundiranjem in še eno uro po zaključku infundiranja.
English: Dizziness, nausea, fatigue and headache have been reported during treatment with ibalizumab (see section 4.8).
Slovenian: Med zdravljenjem z ibalizumabom so poročali o omotici, navzei, utrujenosti in glavobolu (glejte poglavje 4.8).
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.
Slovenian: Priporočeni odmerek ibalizumaba je enkratni polnilni odmerek 2.000 mg, ki mu sledi vzdrževalni odmerek 800 mg vsaka 2 tedna.
English: There are no data on the effects of ibalizumab on human fertility.
Slovenian: Podatkov o učinku ibalizumaba na plodnost pri človeku ni.
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.
Slovenian: virusna obremenitev 35.350 [304-743.000] kopij/ml in število T-celic CD4+ 73 [0-676] celic/mm3.
English: Other side effects Tell your doctor or nurse if you notice any of the following side effects:
Slovenian: Obvestite zdravnika ali medicinsko sestro, če opazite katerega od naslednjih neželenih učinkov:
English: The safety and efficacy of ibalizumab in geriatric patients (≥ 65 years of age) have not been established.
Slovenian: Varnost in učinkovitost ibalizumaba pri starejših bolnikih (starih ≥ 65 let) še nista bili dokazani.
English: It is unknown whether ibalizumab/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se ibalizumab/presnovki izločajo v materino mleko.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (Contains 2 vials of 200 mg)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA (vsebuje 2 200-mg viali)
English: • feeling hot
Slovenian: • občutek vročine
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.
Slovenian: nasproti mestu v domeni 1, ki je potrebno za vezavo molekul MHC razreda II na CD4, in zato ne moti imunskih funkcij, ki jih posreduje CD4.
English: Each vial contains 200 mg of ibalizumab (in 1.33 mL of solution).
Slovenian: Ena viala vsebuje 200 mg ibalizumaba (v 1,33 ml raztopine).
English: If you miss a dose of Trogarzo
Slovenian: Če niste prejeli odmerka zdravila Trogarzo
English: signs of a new infection (called ‘immune reconstitution inflammatory syndrome') Tell your doctor or nurse straight away if you get any of the above (for more information see ‘Serious side effects' in section 4).
Slovenian: Takoj obvestite zdravnika ali medicinsko sestro, če dobite kaj od zgoraj navedenega (za več informacij glejte „Resni neželeni učinki“ v poglavju 4).
English: Ibalizumab should not be administered as an intravenous push or bolus.
Slovenian: Ibalizumab se ne sme dajati v obliki intravenskega potiska ali bolusa.
English: How Trogarzo works
Slovenian: Kako zdravilo Trogarzo deluje
English: A tabulated list of adverse reactions is presented in Table 1.
Slovenian: Seznam neželenih učinkov je prikazan v preglednici 1.
English: See the table below for the appropriate number of vials required to prepare both the loading dose of 2,000 mg and the maintenance doses of 800 mg.
Slovenian: Glejte spodnjo preglednico za ustrezno število vial, ki so potrebne za pripravo polnilnega odmerka 2.000 mg in vzdrževalnih odmerkov 800 mg.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 2 viali
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.
Slovenian: Tretja faza preskušanja TMB-301 je bilo multicentrično klinično preskušanje z enim krakom, v katero je bilo vključenih 40 preiskovancev, okuženih s HIV-1, odpornim proti več zdravilom, ki so prejemali obsežno protiretrovirusno zdravljenje.
English: Histidine
Slovenian: Histidin
English: Dublin 2, D02 T380, Ireland Tel: + 35319201427 regulatoryaffairs@theratech.com
Slovenian: Tel. št.: + 35319201427 regulatoryaffairs@theratech.com
English: Only one subject was found to have anti-ibalizumab antibodies.
Slovenian: Samo za enega preiskovanca je bilo ugotovljeno, da ima protitelesa proti ibalizumabu.
English: Therapy should be initiated by a physician experienced in the management of HIV infection.
Slovenian: Zdravljenje lahko uvede le zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
English: Ibalizumab dose
Slovenian: Odmerek ibalizumaba
English: The pack size is 2 glass vials per carton.
Slovenian: Velikost pakiranja je 2 stekleni viali na škatlo.
English: Ibalizumab vials (Total volume to be withdrawn)
Slovenian: Viale ibalizumaba (skupna prostornina, ki se odvzame)
English: Week 25
Slovenian: 31. oktober 2025
English: (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: (glejte spodaj in poglavje 4.4)
English: Other intravenous diluents must not be used to prepare the ibalizumab solution for infusion.
Slovenian: Za pripravo raztopine ibalizumaba za infundiranje se ne smejo uporabljati druga intravenska razredčila.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of in vitro and in vivo safety assessments.
Slovenian: Predklinični podatki na osnovi običajnih študij o varnosti in vitro in in vivo ne kažejo posebnega tveganja za človeka.
English: 2 mL vial (Type I borosilicate glass) sealed with a stopper (butyl rubber) and an aluminum crimp cap.
Slovenian: 6.5 Vrsta ovojnine in vsebina 2-ml viala (borosilikatno steklo tipa 1), ki je zatesnjena z zamaškom (butilna guma) in aluminijastim pokrovčkom.
English: Diluted ibalizumab solution should be administered by a healthcare professional.
Slovenian: Razredčeno raztopino ibalizumaba mora dati zdravstveni delavec.
English: There were no ibalizumab-related adverse effects (maternal, foetal, or infant) at 110 mg/kg (No-Observed-Adverse-Effect Level, NOAEL).
Slovenian: Pri 110 mg/kg (raven brez opaženih negativnih učinkov (NOAEL - No-Observed-Adverse-Effect Level) ni bilo neželenih učinkov, povezanih z ibalizumabom (pri materii, plodu ali mladičih).
English: See Table 4 below for the appropriate number of vials required to prepare both the loading dose of 2,000 mg and the maintenance doses of 800 mg.
Slovenian: V preglednici 4 je navedeno ustrezno število vial, ki so potrebne za pripravo polnilnega odmerka 2.000 mg in vzdrževalnih odmerkov 800 mg.
English: Ibalizumab should be administered as an intravenous infusion.
Slovenian: Ibalizumab je treba dajati kot intravensko infuzijo.
English: Ibalizumab has a minor influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Ibalizumab ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: No relevant remaining effect of ibalizumab is expected in cases of resistance development.
Slovenian: V primerih razvoja odpornosti ni pričakovati nobenega ustreznega preostalega učinka ibalizumaba.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trogarzo 200 mg sterile concentrate ibalizumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Trogarzo 200 mg sterilen koncentrat ibalizumab i.v.
English: Recommended ibalizumab dose and number of vials per administration Ibalizumab dose
Slovenian: Priporočeni odmerek ibalizumaba in število vial na dajanje Odmerek ibalizumaba
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
English: Tabulated summary of adverse reactions associated with ibalizumab System organ class
Slovenian: Povzetek neželenih učinkov, povezanih z ibalizumabom, v obliki preglednice
English: Subjects on a failing ART regimen continued to receive their failing regimen in addition to the loading dose of ibalizumab.
Slovenian: Preiskovanci z neuspešnim zdravljenjem z ART so poleg polnilnega odmerka ibalizumaba nadaljevali tudi neuspešno zdravljenje.
English: Ibalizumab contains less than 1 mmol sodium (23 mg) in each loading dose of 2,000 mg or maintenance dose of 800 mg and therefore is essentially sodium-free.
Slovenian: Ibalizumab vsebuje v enem polnilnem odmerku 2.000 mg ali v vzdrževalnem odmerku 800 mg manj kot 1 mmol natrija (23 mg), kar bistvu pomeni „brez natrija“.