FrancophonIA/ELRC3.0 huggingface dataset:
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).
Croatian: U slučaju osipa, preporučuje se nadzor bolesnika i prema potrebi primjena simptomatskog liječenja (npr. kortikosteroidi i/ili antihistaminici).
English: Vascular disorders hypertension, labile hypertension, orthostatic hypotension
Croatian: Krvožilni poremećaji hipertenzija, labilna hipertenzija, ortostatska hipotenzija
English: • feeling dizzy, faint or light headed when standing up
Croatian: • omaglica, nesvjestica ili ošamućenost pri ustajanju
English: Ibalizumab vials (Total volume to be withdrawn)
Croatian: Broj bočica ibalizumaba (ukupni volumen koji treba povući)
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.
Croatian: Ako razrijeđenu otopinu ibalizumaba čuvate u hladnjaku, ostavite je prije primjene na sobnoj temperaturi (20 °C do 25 °C) najmanje 30 minuta, ali ne više od četiri sata.
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.
Croatian: Primarna mjera ishoda za djelotvornost bio je udio ispitanika koji su postigli smanjenje virusnog opterećenja za ≥ 0,5 log10 od početka do kraja „razdoblja funkcionalne monoterapije” u usporedbi s udjelom ispitanika koji su postigli smanjenje za ≥ 0,5 log10 od početka do kraja „kontrolnog razdoblja”, kako je definirano u prethodnim odlomcima.
English: If the patient does not experience an infusion-associated adverse reaction, the post-infusion observation time can be reduced to 15 minutes thereafter.
Croatian: Ako se u bolesnika ne pojavi nuspojava povezana s infuzijom, vrijeme praćenja nakon infuzije može se smanjiti na 15 minuta kod sljedećih infuzija.
English: Ibalizumab pharmacokinetics have not been evaluated in paediatric patients.
Croatian: Farmakokinetika ibalizumaba nije ispitana u pedijatrijskih bolesnika.
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.
Croatian: Bočice koje sadrže nerazrijeđeni ibalizumab ili infuzijsku vrećicu s razrijeđenim ibalizumabom mora se baciti ako je otopina mutna, ako je došlo do naglašene promjene boje ili ako su prisutne strane čestice.
English: There were no ibalizumab-related adverse effects (maternal, foetal, or infant) at 110 mg/kg (No-Observed-Adverse-Effect Level, NOAEL).
Croatian: Nije bilo nuspojava (u majki, fetusa ili mladunčadi) povezanih s primjenom doze ibalizumaba od 110 mg/kg (razina doze bez opaženog štetnog učinka (NOAEL)).
English: Instructions on dilution of ibalizumab before use
Croatian: Upute o razrjeđivanju ibalizumaba prije primjene
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.
Croatian: Općenito, do pojave osipa dolazilo je rano (tj. unutar jednog do tri tjedna nakon prve doze ibalizumaba), bili su blagog do umjerenog intenziteta, te su s nastavkom primjene ibalizumaba nestajali unutar jednog do tri tjedna.
English: Ibalizumab concentrate for solution for infusion should be prepared by a healthcare professional using aseptic technique as follows:
Croatian: Ibalizumab koncentrat za otopinu za infuziju treba pripremiti zdravstveni radnik primjenom sljedeće aseptične metode:
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).
Croatian: Lijek Trogarzo u kombinaciji s drugim antiretrovirusnim lijekovima indiciran je za liječenje odraslih osoba zaraženih multirezistentnim virusom HIV-1, u kojih inače nije moguće složiti režim supresivnog antivirusnog liječenja (vidjeti dio 5.1).
English: A tabulated list of adverse reactions is presented in Table 1.
Croatian: Tablični popis nuspojava naveden je u tablici 1.
English: Fifty-five percent of subjects had a ≥ 1 log10 reduction in viral load, and 48% of subjects had a ≥
Croatian: Pedeset i pet posto ispitanika imalo je smanjenje virusnog opterećenja za ≥ 1 log10, a 48 % ispitanika imalo je smanjenje virusnog opterećenja za ≥ 2 log10 u 25. tjednu.
English: Immune system disorders hypersensitivity, immune reconstitution inflammatory syndrome (see below and section 4.4)
Croatian: Poremećaji imunosnog sustava preosjetljivost, upalni sindrom imunosne rekonstitucije (vidjeti u nastavku te dio 4.4)
English: No. of subjects achieving <200 HIV-1 RNA copies/mL (n/N)
Croatian: Broj ispitanika koji su postigli < 200 HIV-1 RNK kopija/ml (n/N)
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).
Croatian: Uočeno je povećanje srednjeg broja CD4+ T limfocita od 62 stanice/mm3 od početka ispitivanja do 25. tjedna (analiza populacije predviđene za liječenje, ITT analiza).
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.
Croatian: Ovaj je epitop smješten na površini receptora CD4 nasuprot mjesta na domeni 1 potrebnog za vezanje MHC molekula razreda II na receptor CD4 i stoga ne utječe na imunosne funkcije posredovane receptorom CD4.
English: What Trogarzo is and what it is used for
Croatian: Što je Trogarzo i za što se koristi
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN
English: Resume maintenance dosing (800 mg) every 2 weeks thereafter.
Croatian: Nakon toga nastavite s primjenom doze održavanja (800 mg) svaka dva tjedna.
English: Keep the vial in the outer carton in order to protect from light.
Croatian: Bočicu čuvajte u vanjskom pakiranju radi zaštite od svjetlosti.
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.
Croatian: Na temelju mehanizma djelovanja i ciljem posredovane dispozicije ibalizumaba, ne očekuju se farmakokinetičke interakcije ibalizumaba s drugim lijekovima.
English: Only one subject was found to have anti-ibalizumab antibodies.
Croatian: Utvrđeno je da je samo jedan ispitanik imao anti-ibalizumab antitijela.
English: - One vial contains 200 mg of ibalizumab in 1.33 mL of solution.
Croatian: - Jedna bočica sadrži 200 mg ibalizumaba u 1,33 ml otopine.
English: Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP.
Croatian: Ovaj se lijek ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza oznake
English: • feeling hot
Croatian: • osjećaj vrućine
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.
Croatian: Ibalizumab sprječava infekciju CD4+ T limfocita virusom HIV-1 vezanjem za domenu 2 receptora CD4 i ometanjem koraka koji slijede nakon vezanja čestica virusa HIV-1, a koji su potrebni za njihov ulazak u stanice domaćina, te sprječavanjem prijenosa virusa koji se dešava fuzijom stanica.
English: This was an observational period to establish baseline HIV viral load.
Croatian: To je bilo opservacijsko razdoblje kako bi se utvrdila početna vrijednost opterećenja virusom HIV-a.
English: MIAS Pharma Limited Suite 2 Stafford House, Strand Road, Portmarnock, Co. Dublin, D13 H525 Ireland
Croatian: MIAS Pharma Limited Suite 2 Stafford House, Strand Road, Portmarnock, Co.
English: Trogarzo is used in combination with other medicines called ‘antiretrovirals'.
Croatian: Trogarzo se primjenjuje u kombinaciji s drugim lijekovima koji se zovu „antiretrovirusni lijekovi (antiretrovirotici)”.
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated.
Croatian: Čuvati i prevoziti na hladnom.
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.
Croatian: U skladu s preporučenim režimom doziranja (jedna udarna doza od 2000 mg nakon čega slijedi doza održavanja od 800 mg svaka dva tjedna), koncentracije ibalizumaba dosegle su stanje dinamičke ravnoteže nakon prve doze održavanja od 800 mg pri čemu je srednja vrijednost najniže koncentracija bila iznad 30 µg/ml tijekom intervala doziranja.
English: There are no data on the effects of ibalizumab on human fertility.
Croatian: Nema podataka o učincima ibalizumaba na plodnost u ljudi.
English: Common papule, pruritus, erythema nodosum
Croatian: Često papule, pruritus, nodozni eritem
English: Ibalizumab was administered to pregnant females at a 110mg/kg weekly dose from gestation Day 20-22 until parturition (approximately 22 doses/animal).
Croatian: Tjedna doza ibalizumaba od 110 mg/kg primjenjivala se u gravidnih ženki 20. - 22. dana gestacije pa sve do poroda (približno 22 doze po životinji).
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.
Croatian: Ispitivanje faze 3, TMB-301, bilo je multicentrično kliničko ispitivanje s jednom skupinom provedeno na 40 prethodno intenzivno liječenih osoba zaraženih virusom HIV-a koji je multirezistentan.
English: Out of the 153 subjects in Phase 2b and 3 clinical studies, one subject experienced a severe rash (non-serious).
Croatian: Od 153 ispitanika obuhvaćenih kliničkim ispitivanjima faze 2b i 3, jedan je ispitanik imao teški osip (osip nije bio ocijenjen kao ozbiljan).
English: Trogarzo has a low sodium content
Croatian: Trogarzo sadrži malu količinu natrija
English: IRIS was reported in 2 subjects out of 153 treated with ibalizumab in Phase 2b and 3 clinical studies (see section 4.8).
Croatian: IRIS je zabilježen u kliničkim ispitivanjima faze 2b i 3 u dva od 153 ispitanika liječenih ibalizumabom (vidjeti dio 4.8).
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.
Croatian: Ispitivanja mapiranja epitopa pokazuju da se ibalizumab veže za konformacijski epitop koji se nalazi ponajprije u domeni 2 izvanstaničnog dijela receptora CD4.
English: The median time to maximum serum concentration (Tmax) of 2,000 mg and 800 mg is 1 hr and 10 min, respectively.
Croatian: Medijan vremena do postizanja vršne koncentracije u serumu (Tmax) za 2000 mg je jedan sat odnosno 10 minuta za 800 mg.
English: What Trogarzo is
Croatian: Što je Trogarzo
English: Ibalizumab, a humanized monoclonal antibody of immunoglobulin G type 4 (IgG4), is a CD4 domain 2-directed HIV-1 inhibitor.
Croatian: Mehanizam djelovanja Ibalizumab, humanizirano monoklonsko antitijelo, imunoglobulin G tipa 4 (IgG4), inhibitor je virusa
English: There is no known antidote to ibalizumab overdose.
Croatian: Nije poznat antidot za predoziranje ibalizumabom.
English: This dose was administered as it is at least 10-fold the estimated free clinical AUC and Cmax for the 800 mg Q2W dose.
Croatian: Ova je doza primijenjena jer su AUC slobodne frakcije i Cmax najmanje 10 puta veći od onog procijenjenog za kliničku dozu od 800 mg jednom svaka dva tjedna.
English: It is unknown if Trogarzo can pass into breast milk.
Croatian: Nije poznato izlučuje li se Trogarzo u majčino mlijeko.
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.
Croatian: Preporučena doza ibalizumaba je jedna udarna doza od 2000 mg, nakon čega slijedi doza održavanja od 800 mg svaka dva tjedna.
English: Theratechnologies International Limited 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland Tel: + 35319201427 regulatoryaffairs@theratech.com
Croatian: Theratechnologies International Limited 10 Earlsfort Terrace, Dublin 2, D02 T380, Irska Tel: + 35319201427 regulatoryaffairs@theratech.com
English: • itchy skin, or skin damage bruising abnormal heartbeat high blood pressure or frequent changes in blood pressure Seen in tests:
Croatian: • poremećeni otkucaji srca • povišeni krvni tlak ili česte promjene krvnog tlaka
English: After the infusion is complete, flush with 30 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
Croatian: Nakon završetka infuzije, isperite infuzijsku liniju s 30 ml 0,9%-tne otopine natrijeva klorida (9 mg/ml) za injekcije.
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.
Croatian: uočena je u većine ispitanika koji su imali virološki neuspjeh, a mogla bi biti povezana s genotipskim promjenama u sekvenci koja kodira ovojnicu virusa HIV-1, što rezultira gubitkom mjesta potencijalne N-vezane glikozilacije (engl. potential N-linked glycosylation sites, PNGS) u V5 petlji gp120.
English: Proportion of subjects achieving a ≥ 0.5 log10
Croatian: Udio ispitanika koji su postigli smanjenje virusnog opterećenja za ≥ 0,5 log10
English: There are no data from the use of ibalizumab in pregnant women.
Croatian: Nema podataka o primjeni ibalizumaba u trudnica.
English: Trogarzo contains less than 1 mmol sodium (23 mg) in each dose and therefore is essentially sodium-free.
Croatian: Trogarzo sadrži manje od 1 mmol natrija (23 mg) u svakoj dozi, tj. zanemarive količine natrija.
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).
Croatian: U drugom tjednu, srednja vrijednost smanjenja virusnog opterećenja iznosila je 0,87 log10 kopija/ml u skupini A, 1,15 log10 kopija/ml u skupini B i 0,38 log10 kopija/ml u skupini koja je primala placebo (p = 0,003 nasuprot skupini A, p < 0,001 nasuprot skupini B).
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.
Croatian: Tijekom sudjelovanja u ispitivanjima, svih 153 ispitanika obuhvaćenih kliničkim ispitivanjima faze 2b i 3 testirano je na prisutnost anti-ibalizumab IgG antitijela.
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).
Croatian: jednom tjedno za prvih devet doza (do posjete nakon 8. tjedna), zatim i.v. infuzije od 15 mg/kg ibalizumaba svaka dva tjedna (skupina A); 10 mg/kg i.v. infuzije ibalizumaba jednom tjedno za prvih devet doza (do posjete nakon 8. tjedna), zatim i.v. infuzije od 10 mg/kg ibalizumaba svaka dva tjedna (skupina B); ili i.v. infuzije placeba jednom tjedno za prvih devet doza (do posjete nakon 8. tjedna), zatim i.v. infuzije placeba svaka dva tjedna (skupina koja je primala placebo).
English: Virologic response at week 25 by baseline CD4 cell count, integrase inhibitor resistance and Overall Susceptibility Score (OSS)* for study TMB-301
Croatian: Tablica 3. Virološki odgovor u 25. tjednu prema početnom broju CD4 stanica, rezistenciji na inhibitor integraze i rezultatu ukupne osjetljivosti (OSS)* za ispitivanje TMB-301 Broj ispitanika koji su postigli < 50 HIV-1 RNK kopija/ml (n/N)
English: More than one vial of Trogarzo will be needed to get the required dose.
Croatian: Za potrebnu dozu trebat će više od jedne bočice lijeka Trogarzo.
English: Ibalizumab is produced in murine myeloma non-secreting (NS0) cells by recombinant DNA technology.
Croatian: Ibalizumab se proizvodi tehnologijom rekombinantne DNK u nesekrecijskim stanicama mišjeg mijeloma (NS0).
English: Nervous system disorders dizziness, headache, paraesthesia
Croatian: Poremećaji živčanog sustava omaglica, glavobolja, parestezija
English: Diluted ibalizumab solution should be administered by a healthcare professional.
Croatian: Razrijeđenu otopinu ibalizumaba mora primjeniti zdravstveni radnik.
English: Colourless to slightly yellow, clear to slightly opalescent aqueous solution.
Croatian: Bezbojna do blago žuta, bistra do blago opalescentna vodena otopina.
English: Dublin 2, D02 T380, Ireland Tel: + 35319201427 regulatoryaffairs@theratech.com
Croatian: 10 Earlsfort Terrace, Dublin 2, D02 T380, Irska Tel: + 35319201427 regulatoryaffairs@theratech.com
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).
Croatian: Do 16. tjedna, tj. prije mogućnosti prebacivanja bolesnika iz skupine koja je primala placebo na dozu ibalizumaba od 15 mg/kg svaka dva tjedna i/ili promjene OBR-a za sve bolesnike, srednja vrijednost smanjenja virusnog opterećenja iznosila je 1,07 log10 kopija/ml u skupini A, 1,33 log10 kopija/ml u skupini B i 0,26 log10 kopija/ml u skupini koja je primala placebo (p = 0,002 nasuprot skupini A, p < 0,001 nasuprot skupini B).
English: A pre- and post-natal developmental study was performed in cynomolgus monkeys.
Croatian: Ispitivanje prenatalnog i postnatalnog razvoja provedeno je na makaki majmunima.
English: Common feeling hot
Croatian: Često osjećaj vrućine
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.
Croatian: Ibalizumab sadrži manje od 1 mmol natrija (23 mg) u svakoj udarnoj dozi od 2000 mg ili u dozi održavanja od 800 mg, tj. sadrži zanemarive količine natrija.
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.
Croatian: Taj je ispitanik tijekom liječenja ibalizumabom u različito vrijeme imao osam nuspojava osipa, uključujući jedan događaj makularnog osipa, jedan događaj generaliziranog osipa i šest događaja makulopapularnog osipa.
English: Tell your doctor or nurse if you notice any of the side effects listed above.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako primijetite bilo koju od prethodno navedenih nuspojava.
English: Trogarzo 200 mg concentrate for solution for infusion
Croatian: Trogarzo 200 mg koncentrat za otopinu za infuziju
English: Ibalizumab should not be administered as an intravenous push or bolus.
Croatian: Ibalizumab se ne smije primjenjivati kao brza intravenska injekcija ili bolus.
English: What Trogarzo is used for
Croatian: Za što se Trogarzo koristi
English: No action was taken with ibalizumab in response to these events.
Croatian: Kao odgovor na te događaje nisu poduzeti nikakvi postupci u vezi s primjenom ibalizumaba.
English: It will be used together with other HIV medicines called ‘antiretrovirals'.
Croatian: Također će se primjenjivati zajedno s drugim lijekovima protiv HIV-a koji se zovu „antiretrovirusni lijekovi (antiretrovirotici)”.
English: Marketing Authorisation Holder and manufacturer Theratechnologies International Limited 10 Earlsfort Terrace,
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Theratechnologies International Limited
English: **Includes pooled terms “rash”, “rash erythematous”, “rash generalized”, “rash macular”, “rash maculopapular”, “rash pruritic” and “rash papular”.
Croatian: **Uključuje skupne pojmove „osip”, „eritematozni osip”, „generalizirani osip”, „makularni osip”, „makulopapularni osip”,
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.
Croatian: *točan interval pouzdanosti od 95 % ** p < 0,0001 na temelju McNemarovog testa kojim je uspoređen udio ispitanika koji su postigli smanjenje virusnog opterećenja za ≥ 0,5 log10 na kraju kontrolnog razdoblja i razdoblja funkcionalne monoterapije.
English: It is unknown whether ibalizumab/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se ibalizumab / njegovi metaboliti u majčino mlijeko.
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.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Prije primjene lijek vizualno pregledajte kako biste isključili prisutnost stranih čestica i promjene boje.
English: Proportion of subjects achieving a ≥ 0.5 log10 decrease in viral load at the end of the control and functional monotherapy periods
Croatian: Udio ispitanika koji su postigli smanjenje virusnog opterećenja za ≥ 0,5 log10 na kraju kontrolnog razdoblja i razdoblja funkcionalne monoterapije
English: Trogarzo attaches to the CD4 receptor and blocks HIV from entering and infecting your blood cells.
Croatian: CD4 i sprječava virus HIV-a da uđe u krvne stanice i zarazi ih.
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.
Croatian: Na početku ispitivanja, medijan [min - maks] virusnog opterećenja bio je 35,350 [304 - 743,000] kopija/ml, a broj CD4+ T limfocita
English: • diarrhoea feeling sick (nausea) or being sick (vomiting) dizziness headache feeling tired dry skin dermatitis - a type of eczema with dry itchy skin pain and feeling numb in hands, feet or legs
Croatian: • dermatitis - vrsta ekcema sa suhom kožom koja svrbi • bol i utrnulost šaka, stopala ili nogu
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.
Croatian: dana liječenja radi utvrđivanja primarne mjere ishoda, a nakon toga je osnovni režim optimiziran kako bi uključivao najmanje jedan lijek na koji je virus ispitanika bio osjetljiv.
English: How Trogarzo works
Croatian: Kako Trogarzo djeluje
English: Dizziness, nausea, fatigue and headache have been reported during treatment with ibalizumab (see section 4.8).
Croatian: Tijekom liječenja ibalizumabom zabilježene su omaglica, mučnina, umor i glavobolja (vidjeti dio 4.8).
English: Other side effects Tell your doctor or nurse if you notice any of the following side effects:
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako primijetite bilo koju od sljedećih nuspojava:
English: Common tremor
Croatian: Često tremor
English: Ibalizumab is administered as an IV infusion.
Croatian: Ibalizumab se primjenjuje kao i.v. infuzija.