FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: • Obdobje nadzorovanja (od 0. do 6. dne): Preiskovanci so bili bodisi spremljani med njihovim trenutnim neuspešnim zdravljenjem bodisi niso prejemali nobenega zdravljenja po neuspešnem zdravljenju in prekinitvi zdravljenja v 8 tednih pred presejalnim pregledom.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Nosečnost Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom,
English: The duration of the first infusion (loading dose) should be no less than 30 minutes.
Slovenian: Trajanje prve infuzije (polnilni odmerek) ne sme biti krajše od 30 minut.
English: It is unknown if Trogarzo can pass into breast milk.
Slovenian: Ni znano, ali lahko zdravilo Trogarzo prehaja v materino mleko.
English: Pharmacotherapeutic group: Antivirals for systemic use, other antivirals.
Slovenian: Farmakoterapevtska skupina: protivirusna zdravila za sistemsko uporabo, druga protivirusna zdravila.
English: • Discard partially used vials or empty vials of ibalizumab and any unused portion of the diluted ibalizumab solution in accordance with local requirements.
Slovenian: • Delno uporabljene viale ali prazne viale ibalizumaba in vsakršen neporabljen del razredčene raztopine ibalizumaba zavrzite v skladu z lokalnimi predpisi.
English: What you need to know before you use Trogarzo 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Trogarzo 3.
English: • Maintenance period (Day 14 to Week 25): On Day 14 of the treatment period, viral load was assessed for the primary endpoint, and thereafter the background regimen was optimized to include at least one drug to which the subject's virus was susceptible.
Slovenian: • Vzdrževalno obdobje (od 14. dne do 25. tedna): 14. dan obdobja zdravljenja je bila kot primarni opazovani dogodek ocenjena virusna obremenitev in nato optimizirana osnovna shema, ki je vključevala vsaj eno zdravilo, za katero je bil virus preiskovanca dovzeten.
English: WuXi Biologics Co, Ltd 108 Meiliang Road, MaShan Binhu District, Wuxi, 214092, China
Slovenian: Wuxi Biologics Co, Ltd 108 Meiliang Road, MaShan Binhu District, Wuxi Jiangsu, 214092, Kitajska
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.
Slovenian: Volumen porazdelitve ibalizumaba je približno 4,8 l, kar je na podlagi opravljene farmakokinetične analize populacije primerljivo z vaskularnim prostorom.
English: Rashes were common.
Slovenian: Izpuščaji so bili pogosti.
English: This leaflet was last revised in month YYYY.
Slovenian: Navodilo je bilo nazadnje revidirano mesec LLLL.
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Slovenian: Študije vpliva na sposobnost razmnoževanja na živalih niso zadostne (glejte poglavje 5.3).
English: The subject received ibalizumab therapy for an additional 1.5 years before discontinuing voluntarily with an undetectable viral load (<50 copies/mL).
Slovenian: Preiskovanec je prejemal zdravljenje z ibalizumabom dodatnega 1,5 leta, preden je prostovoljno prekinil zdravljenje ob nezaznavni virusni obremenitvi (< 50 kopij/ml).
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and pneumocystis jiroveci pneumonia.
Slovenian: Relevantni primeri so citomegalovirusni retinitis, generalizirane in/ali žariščne okužbe z mikobakterijami in s Pneumocystis jiroveci povzročena pljučnica.
English: The results suggest that ibalizumab concentration decreases as body weight increases.
Slovenian: Rezultati kažejo, da se koncentracije ibalizumaba s povečanjem telesne mase znižajo.
English: Hydrochloric acid (for pH-adjustment) Water for injections
Slovenian: Klorovodikova kislina (za prilagoditev pH) Voda za injekcije
English: Virologic response CD4 cell counts (cells/ mm3)
Slovenian: virološki odziv število celic CD4 (celice/mm3)
English: How to receive Trogarzo You will be given Trogarzo under the supervision of an experienced doctor or nurse.
Slovenian: Zdravilo Trogarzo boste prejeli pod nadzorom izkušenega zdravnika ali medicinske sestre.
English: Ibalizumab is expected to degrade to small peptides and individual amino acids.
Slovenian: Ibalizumab naj bi se razgradil na majhne peptide in posamezne aminokisline.
English: Look out for new signs of infection after receiving Trogarzo; these can be different from person to person depending on the type of infection that was hidden and might include fever, headache, difficulty breathing, stomach ache, coughing and swollen glands (lumps and bumps on your body, neck, armpit or groin).
Slovenian: Po prejemu zdravila Trogarzo bodite pozorni na nove znake okužbe; ti se lahko od osebe do osebe razlikujejo, odvisno od vrste okužbe, ki je bila prikrita, in lahko vključujejo zvišano telesno temperaturo, glavobol, težave pri dihanju, bolečino v trebuhu, kašelj in otekle bezgavke (zatrdline in bulice na telesu, vratu, pod pazduho ali v dimljah).
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.
Slovenian: - Druge sestavine zdravila so saharoza, natrijev klorid (glejte poglavje 2 „Zdravilo Trogarzo ima nizko vsebnost natrija“), polisorbat 80, histidin, klorovodikova kislina, voda za injekcije.
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).
Slovenian: Preobčutljivost Za enega izmed 153 preiskovancev so poročali, da se mu je pojavila preobčutljivost (alergijska reakcija) 21. dan (tj. 7 dni po 2. infuziji ibalizumaba).
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.
Slovenian: Pri bolnikih, okuženih s HIV, s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (cART - combined antiretroviral treatment) nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične patogene in povzroči resna klinična stanja ali poslabšanje simptomov.
English: Pack of 2 vials.
Slovenian: Pakiranje vsebuje 2 viali.
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.
Slovenian: Preiskovanci so že prejemali obsežna zdravljenja: 53 % udeležencev je bilo zdravljenih z 10 ali več protiretrovirusnimi zdravili pred vključitvijo v preskušanje; 98 % jih je bilo zdravljenih z NRTI, 98 % z zaviralci proteaz, 80 % z NNRTI, 78 % z INSTI, 30 % z zaviralci fuzije gp41 in 20 % z antagonisti receptorjev CCR5.
English: • itchy skin, or skin damage bruising abnormal heartbeat high blood pressure or frequent changes in blood pressure Seen in tests:
Slovenian: • povišan krvni tlak ali pogoste spremembe krvnega tlaka Opaženi pri preiskavah:
English: If you could get pregnant while taking Trogarzo, you need to use a reliable method of barrier contraception (for example, a condom) with other methods of contraception including oral contraceptive (the pill) or other hormonal contraceptives (for example, implants or injections), to prevent pregnancy.
Slovenian: Če bi lahko med jemanjem zdravila Trogarzo zanosili, morate za preprečitev nosečnosti poleg drugih načinov kontracepcije, vključno s peroralnimi (kontracepcijske tablete) ali drugimi hormonskimi kontracepcijskimi sredstvi (na primer vsadki, injekcije), uporabljati zanesljiv način mehanske kontracepcije (na primer kondom).
English: Common (may affect up to 1 in 10 people): skin rash
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): • kožni izpuščaj
English: Prophylactic medication is not warranted prior to each infusion.
Slovenian: Profilaktično zdravljenje pred vsakim infundiranjem ni potrebno.
English: Colourless to slightly yellow, clear to slightly opalescent aqueous solution.
Slovenian: Brezbarvna do rahlo rumena, bistra do rahlo opalescentna vodna raztopina.
English: In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and given appropriate symptomatic treatment.
Slovenian: V primeru prevelikega odmerjanja se priporoča spremljanje bolnika za morebitne znake ali simptome neželenih učinkov in ustrezno simptomatsko zdravljenje.
English: Your doctor has prescribed Trogarzo to help control your HIV infection.
Slovenian: Zdravnik vam je predpisal zdravilo Trogarzo za pomoč pri obvladovanju okužbe z virusom HIV.
English: As an example, an OSS of 2 would indicate that the HIV-1 isolate tested was fully susceptible to two drugs in the OBR.
Slovenian: Na primer, OSS 2 kaže, da je testirani izolat HIV-1 popolnoma dovzeten za dve zdravili v OBR.
English: In general, rashes had an early onset (i.e. within 1 to 3 weeks of the first dose of ibalizumab), were mild to moderate in intensity, and resolved within 1-3 weeks with continued ibalizumab administration.
Slovenian: Na splošno so se izpuščaji začeli zgodaj (tj. v 1 do 3 tednih po prvem odmerku ibalizumaba), po intenzivnosti so bili blagi do zmerni in so izginili v 1 do 3 tednih z nadaljevanjem uporabe ibalizumaba.
English: In case of rash, it is recommended that the patient be monitored and symptomatic therapy be initiated when appropriate (e.g. cortisteroids and/or anti-histamine medicinal products).
Slovenian: V primeru izpuščajev je priporočljivo bolnika spremljati in po potrebi začeti simptomatsko zdravljenje (npr. kortikosteroidi in/ali antihistaminiki).
English: • feeling dizzy, faint or light headed when standing up
Slovenian: • občutek omotice, omedlevice ali šibkosti pri vstajanju
English: Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for developmental effects was 110 mg/kg.
Slovenian: Pod pogoji te študije je bila raven brez brez opaženih negativnih učinkov (NOAEL) na razvoj 110 mg/kg.
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.
Slovenian: Opravljena je bila populacijska farmakokinetična analiza, da bi raziskali možne učinke izbranih sospremenljivk (starost, telesna masa, spol, izhodiščno število celic CD4+) na farmakokinetiko ibalizumaba.
English: IRIS was reported in 2 subjects out of 153 treated with ibalizumab in Phase 2b and 3 clinical studies (see section 4.8).
Slovenian: O VSIO so poročali pri 2 od 153 oseb, zdravljenih z ibalizumabom v 2.b in 3. fazi kliničnih študij (glejte poglavje 4.8).
English: Loading dose of 2,000 mg
Slovenian: polnilni odmerek 2.000 mg
English: (≥1/10); common (≥1/100 to < 1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000);
Slovenian: (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Virologic response at week 25 by baseline CD4 cell count, integrase inhibitor resistance and Overall Susceptibility Score (OSS)* for study TMB-301
Slovenian: Virološki odziv v 25. tednu glede na izhodiščno število celic CD4, odpornost proti zaviralcem integraze in skupno oceno občutljivosti (OSS)* za študijo TMB-301
English: The safety and efficacy of ibalizumab in children under the age of 18 years have not yet been established.
Slovenian: Varnost in učinkovitost ibalizumaba pri otrocih in mladostnikih, starih manj kot 18 let, še nista bili dokazani.
English: This period was to establish the virologic activity of ibalizumab.
Slovenian: To obdobje naj bi vzpostavilo virološko aktivnost ibalizumaba.
English: The results of the primary endpoint analysis are shown in Table 2 below.
Slovenian: Rezultati analize primarnih opazovanih dogodkov so prikazani v preglednici 2.
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.
Slovenian: Celice CD4+ so bile pri mladičih samic, ki so prejemale zdravilo, začasno supresirane zaradi BD14-91 v primerjavi z živalmi iz kontrolne skupine, vendar ni bilo nadaljnjega vpliva na imunokompetenco mladičev.
English: Trogarzo has a low sodium content
Slovenian: Zdravilo Trogarzo ima nizko vsebnost natrija
English: Ibalizumab concentrate for solution for infusion should be prepared by a healthcare professional using aseptic technique as follows:
Slovenian: Koncentrat ibalizumaba za raztopino za infundiranje mora pripraviti zdravstveni delavec z aseptično tehniko, kot sledi:
English: Such non-linear effects in clearance are common for monoclonal antibodies targeting cell surface molecules, such as CD4.
Slovenian: Takšni nelinearni učinki, kar zadeva očistek, so običajni za monoklonska protitelesa, usmerjena proti molekulam na celični površini, kot je CD4.
English: • Functional monotherapy period (Day 7 to Day 13): All subjects received a 2,000 mg loading dose of ibalizumab on Day 7.
Slovenian: • Obdobje funkcionalne monoterapije (od 7. do 13. dne): Vsi preiskovanci so na 7. dan prejeli 2.000 mg ibalizumaba kot polnilni odmerek.
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.
Slovenian: Rezultati fenotipskih in genotipskih testov niso pokazali navzkrižne odpornosti med ibalizumabom in katerim koli odobrenim skupinam protiretrovirusnih zdravil.
English: Decreased susceptibility to ibalizumab does not alter susceptibility to other approved agents and does not result in the selection of CD4-independent viral isolates.
Slovenian: Zmanjšana dovzetnost za ibalizumab ne spremeni občutljivosti za druge odobrene učinkovine in ne povzroči selekcije virusnih izolatov, neodvisnih od CD4.
English: Keep the vial in the outer carton in order to protect from light.
Slovenian: Vialo shranjujte v zunanji škatli za zagotovitev zaščite pred svetlobo.
English: Your doctor or nurse will monitor you during the Trogarzo infusion and for a period of time after your infusion.
Slovenian: Zdravnik ali medicinska sestra vas bosta med infuzijo zdravila Trogarzo in še nekaj časa po njej opazovala.
English: Ibalizumab was generally well tolerated in pregnant monkeys and in their offspring, when evaluated through 180 ± 2 days postpartum.
Slovenian: Ibalizumab so breje opice in njihovi potomci na splošno dobro prenašali; ocenjevali so jih v 180 dni ± 2 dneva po porodu.
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.
Slovenian: Zmanjšana dovzetnost za ibalizumab je bila ugotovljena pri večini bolnikov, pri katerih je do 24. tedna prišlo do virološkega neuspeha v ključni študiji.
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.
Slovenian: Po uporabi ibalizumaba je pri klinično pomembnem odmerku 800-2.000 mg se je največja serumska koncentracija (Cmax) povečala sorazmerno z odmerkom, medtem ko se je površina pod krivuljo koncentracija - čas (AUC) povečala bolj kot sorazmerno z odmerkom.
English: If you are breast-feeding, or thinking about breast-feeding:
Slovenian: Če dojite ali razmišljate, da bi dojili:
English: Grade 3 creatinine elevations occurred frequently in subjects with underlying renal disease, risk factors for renal disease, and/or in subjects taking concomitant medications known to be nephrotoxic.
Slovenian: Zvišanje kreatinina 3. stopnje je bilo pogosto pri preiskovancih z osnovno ledvično boleznijo, dejavniki tveganja za ledvično bolezen in/ali pri preiskovancih, ki so sočasno jemali zdravila, za katera je znano, da so nefrotoksična.
English: If you stop having Trogarzo Keep having Trogarzo infusions until your doctor tells you to stop.
Slovenian: Prejemanje infuzij zdravila Trogarzo nadaljujte, dokler vam zdravnik ne naroči, da prenehajte.
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.
Slovenian: (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: As of Week 16, patients in Placebo arm who experienced virologic failure had the option of receiving 15 mg/kg open-label ibalizumab every 2 weeks and/or switching to a new OBR.
Slovenian: Od 16. tedna dalje so imeli bolniki v skupini, ki je prejemala placebo in ki so doživeli virološki neuspeh, možnost prejemanja 15 m/kg odprtega ibalizumaba vsaka 2 tedna in/ali prehoda na novo OBR.
English: What Trogarzo is and what it is used for 2.
Slovenian: Kaj je zdravilo Trogarzo in za kaj ga uporabljamo 2.
English: You can still pass on HIV when taking this medicine, if you have detectable levels of HIV in your body.
Slovenian: Ko jemljete to zdravilo, lahko virus HIV še vedno prenesete, če imate v telesu zaznavne ravni virusa HIV.
English: Ibalizumab is produced in murine myeloma non-secreting (NS0) cells by recombinant DNA technology.
Slovenian: Ibalizumab se proizvaja v nesekrecijskih (NS0) celicah murinskega mieloma s pomočjo tehnologije rekombinantne DNK.
English: No action was taken with ibalizumab in response to these events.
Slovenian: V odgovor na te dogodke niso bili izvedeni nobeni ukrepi, kar zadeva ibalizumab.
English: Ibalizumab pharmacokinetics in geriatric patients (≥ 65 years of age) is limited (n = 5).
Slovenian: Starejša populacija Podatkov o farmakokinetiki ibalizumaba pri geriatričnih bolnikih (≥ 65 let) je malo (n = 5).
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora prvo PSUR za to zdravilo predložiti v 6 mesecih po pridobitvi dovoljenja za promet.
English: Instructions on dilution of ibalizumab before use
Slovenian: Navodila za redčenje ibalizumaba pred uporabo
English: • Remove the flip-off cap from the vial and wipe with an alcohol swab.
Slovenian: • Odstranite snemno zaporko z viale in vialo obrišite z alkoholnim zložencem.
English: Trogarzo attaches to the CD4 receptor and blocks HIV from entering and infecting your blood cells.
Slovenian: Zdravilo Trogarzo se veže na receptor CD4 in virusu HIV prepreči vstop in okuženje krvnih celic.
English: Genotoxicity and carcinogenicity studies have not been conducted.
Slovenian: Genotoksičnost, rakotvorni potencial Študij genotoksičnosti in rakotvornosti niso izvedli.
English: Store in a refrigerator (2°C to 8°C).
Slovenian: Shranjujte v hladilniku (2-8 °C).
English: This was an observational period to establish baseline HIV viral load.
Slovenian: To je bilo opazovalno obdobje za določitev izhodiščne virusne obremenitve z virusom HI.V.
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.
Slovenian: Ta preiskovanec je imel 8 različnih neželenih reakcij z izpuščaji, vključno z 1 pojavom makularnega izpuščaja, 1 pojavom generaliziranega izpuščaja in 6 pojavi makulopapularnega izpuščaja v različnih obdobjih med zdravljenjem z ibalizumabom.
English: It will be used together with other HIV medicines called ‘antiretrovirals'.
Slovenian: Uporabljalo se bo skupaj z drugimi zdravili za zdravljenje okužbe z virusom HIV, imenovanimi „protiretrovirusna zdravila“.
English: If the patient does not experience an infusion-associated adverse reaction, the post-infusion observation time can be reduced to 15 minutes thereafter.
Slovenian: Če se pri bolniku ne pojavijo neželeni učinki, povezani z infuzijo, se lahko čas opazovanja po infuziji skrajša na 15 minut.
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.
Slovenian: Po dajanju enkratnih odmerkov 10 mg/kg in 25 mg/kg ibalizumaba je očistek od 0,5 do 0,36 ml/h/kg in razpolovni čas izločanja 37,8 ure oziroma 64,1 ure.
English: Specific metabolism studies were not conducted because ibalizumab is a protein.
Slovenian: Specifičnih študij presnove niso opravili, ker je ibalizumab beljakovina.
English: Epitope mapping studies indicate that ibalizumab binds to a conformational epitope located primarily in domain 2 of the extracellular portion of the CD4 receptor.
Slovenian: Študije kartiranja epitopa kažejo, da se ibalizumab veže na konformacijski epitop, ki se nahaja predvsem na domeni 2 izvenceličnega dela receptorja CD4.
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.
Slovenian: Primarno opazovani dogodek učinkovitosti je bil delež preiskovancev, ki so dosegli zmanjšanje virusne obremenitve za ≥ 0,5 log10 od začetka do konca obdobja funkcionalne monoterapije, v primerjavi z deležem tistih, ki so dosegli zmanjšanje za ≥ 0,5 log10 od začetka do konca obdobja nadzorovanja, kot je opredeljeno zgoraj.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 200 mg
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 200 mg
English: Vials containing non-diluted ibalizumab or infusion bag containing diluted ibalizumab must be discarded if solution is cloudy, if there is pronounced discoloration or if there is foreign particulate matter.
Slovenian: Viale, ki vsebujejo nerazredčen ibalizumab, ali infuzijsko vrečko z razredčenim ibalizumabom je treba zavreči, če je raztopina motna, če je prisotna izrazita sprememba barve ali če vsebuje tujke.
English: Study TNX-355.03 was a multicenter, randomized, double-blinded, placebo-controlled, multi-dose, 3arm safety and efficacy study in 82 subjects with HIV-1 and who were failing or had failed highly active antiretroviral therapy.
Slovenian: Študija TNX-355.03 je bila multicentrična, randomizirana, dvojno slepa študija varnosti in učinkovitosti, nadzorovana s placebom, s tremi kraki, z 82 preiskovanci, okuženimi z virusom HIV-1, pri katerih visoko aktivno zdravljenje s protiretrovirusnimi zdravili ni delovalo.
English: You must not be given Trogarzo: - if you are allergic to ibalizumab or any of the other ingredients of this medicine (listed in section
Slovenian: - če ste alergični na ibalizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Ibalizumab, a humanized monoclonal antibody of immunoglobulin G type 4 (IgG4), is a CD4 domain 2-directed HIV-1 inhibitor.
Slovenian: Mehanizem delovanja Ibalizumab, humanizirano monoklonsko protitelo imunoglobulin G tipa 4 (IgG4), je zaviralec HIV-1,
English: Ibalizumab was administered to pregnant females at a 110mg/kg weekly dose from gestation Day 20-22 until parturition (approximately 22 doses/animal).
Slovenian: Ibalizumab so dajali brejim samicam v tedenskem odmerku 110 mg/kg od 20. do 22. dneva gestacije do poroda (približno 22 odmerkov/žival).