FrancophonIA/ELRC3.0 huggingface dataset:
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).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Trogarzo u jednoj ili više podskupina pedijatrijske populacije za liječenje infekcije virusom HIV-1 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Immune reconstitution inflammatory syndrome (IRIS)
Croatian: Upalni sindrom imunosne rekonstitucije (IRIS)
English: If the treating physician determines there is no additional clinical benefit for the patient in terms of viral load reduction, discontinuation of ibalizumab treatment should be considered, see section 5.1.
Croatian: Ako liječnik koji vodi liječenje utvrdi da ne postoji dodatna klinička korist za bolesnika u smislu smanjenja virusnog opterećenja, potrebno je razmotriti prekid liječenja ibalizumabom, vidjeti dio 5.1.
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.
Croatian: Međutim, CD4 + stanice u mladunčadi liječenih ženki bile su privremeno suprimirane tijekom 14-91 dana nakon okota u usporedbi s kontrolnom skupinom, no nije bilo dodatnog učinka na imunokompetentnost mladunčadi.
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.
Croatian: Ispitanici su morali imati virusno opterećenje veće od 1000 kopija/ml i dokumentiranu rezistenciju na najmanje jedan antiretrovirotik iz tri klase antiretrovirusnih lijekova izmjereno ispitivanjem rezistencije.
English: Human IgG is known to be excreted in breast milk during the first days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to breast-fed infants cannot be excluded during this short period and ibalizumab should not be used during breast-feeding.
Croatian: Poznato je da se ljudski imunoglobulin IgG izlučuje u majčinom mlijeku tijekom prvih dana nakon poroda, što se ubrzo smanjuje na niske koncentracije; stoga se tijekom ovog kratkog razdoblja ne može isključiti rizik za dojenčad te se ibalizumab ne smije primjenjivati tijekom dojenja.
English: Ibalizumab is not recommended during pregnancy.
Croatian: Ibalizumab se ne preporučuje tijekom trudnoće.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 200 mg
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 200 mg
English: WuXi Biologics Co, Ltd 108 Meiliang Road, MaShan Binhu District, Wuxi, 214092, China
Croatian: WuXi Biologics Co, Ltd 108 Meiliang Road, MaShan Binhu District, Wuxi, 214092, Kina
English: The subject received ibalizumab therapy for an additional 1.5 years before discontinuing voluntarily with an undetectable viral load (<50 copies/mL).
Croatian: Ta je osoba primala terapiju ibalizumabom dodatnih 1,5 godina prije nego što je dobrovoljno prekinula liječenje s nemjerljivim virusnim opterećenjem (< 50 kopija/ml).
English: If you stop having Trogarzo Keep having Trogarzo infusions until your doctor tells you to stop.
Croatian: Nastavite s infuzijama lijeka Trogarzo dok Vam liječnik ne kaže da prestanete.
English: This leaflet was last revised in month YYYY.
Croatian: Ova uputa je zadnji put revidirana u mjesec GGGG.
English: Women who are HIV-positive must not breast feed because HIV infection can be passed on to the baby in breast milk.
Croatian: Dojenje Žene koje su HIV-pozitivne ne smiju dojiti jer se infekcija HIV-om može majčinim mlijekom prenijeti na dijete.
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description
Croatian: Nositelj odobrenja dužan je, unutar navedenog vremenskog roka, provesti niže navedene mjere: Opis
English: Post-authorisation efficacy study (PAES):
Croatian: Ispitivanje djelotvornosti lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PAES):
English: The duration of the first infusion (loading dose) should be no less than 30 minutes.
Croatian: Trajanje prve infuzije (udarna doza) ne smije biti kraće od 30 minuta.
English: All patients must be observed during and for 1 hour after completion of ibalizumab administration for at least the first infusion.
Croatian: Sve bolesnike mora se promatrati tijekom primjene i jedan sat nakon završetka primjene ibalizumaba, barem prilikom prve infuzije.
English: Cardiac disorders ventricular extrasystoles, electrocardiogram abnormal
Croatian: Srčani poremećaji ventrikularne ekstrasistole, abnormalan elektrokardiogram
English: The pack size is 2 glass vials per carton.
Croatian: Veličina pakiranja je dvije staklene bočice po kutiji.
English: This period was to establish the safety and durability of virologic suppression of ibalizumab when used in combination with an optimized background regimen.
Croatian: Svrha ovog razdoblja bila je utvrditi sigurnost i trajnost virološke supresije pri primjeni ibalizumaba u kombinaciji s optimiziranim osnovnim režimom.
English: The HIV virus infects cells in your blood called ‘CD4' or ‘T-cells'.
Croatian: Virus HIV-a inficira stanice u Vašoj krvi naziva „CD4” ili „T lifmociti”.
English: Store in a refrigerator (2°C to 8°C).
Croatian: Držati u hladnjaku (2 °C - 8 °C).
English: Ibalizumab pharmacokinetics in geriatric patients (≥ 65 years of age) is limited (n = 5).
Croatian: Farmakokinetika ibalizumaba u gerijatrijskih bolesnika (≥ 65 godina) je ograničena (n = 5).
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and pneumocystis jiroveci pneumonia.
Croatian: Relevantni primjeri uključuju citomegalovirusni retinitis, generalizirane i/ili fokalne mikobakterijske infekcije i upalu pluća kojoj je uzročnik pneumocystis jiroveci.
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.
Croatian: Kao primjer, OSS 2 ukazuje na to da je testirani HIV-1 izolat bio u potpunosti osjetljiv na dva lijeka u
English: This medicine reduces the amount of HIV in your body.
Croatian: Ovaj lijek smanjuje količinu HIV-a u Vašem tijelu.
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.
Croatian: Provedena je populacijska farmakokinetička analiza kako bi se istražili potencijalni učinci odabranih kovarijata (dob, tjelesna težina, spol, početni broj CD4 + stanica) na farmakokinetiku ibalizumaba.
English: Ibalizumab is expected to degrade to small peptides and individual amino acids.
Croatian: Očekuje se da će se ibalizumab razgraditi na male peptide i pojedinačne aminokiseline.
English: CD4 cells are a type of white blood cell that are important in helping your body to fight infection.
Croatian: CD4 stanice su vrsta bijelih krvnih stanica koje imaju važnu ulogu u obrani organizma od infekcija.
English: You can still pass on HIV when taking this medicine, if you have detectable levels of HIV in your body.
Croatian: I dalje možete prenijeti HIV dok uzimate ovaj lijek ako su razine HIV-a u Vašem tijelu mjerljive postojećim testovima.
English: Pack of 2 vials.
Croatian: Pakiranje od dvije bočice.
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.
Croatian: • Kontrolno razdoblje (od nultog do 6. dana): Ispitanici su bili su pod nadzorom na postojećoj terapiji koja nije postizala odgovor ili nisu primali terapiju ako su imali terapijski neuspjeh, te su prekinuli liječenje unutar osam tjedana prije probira.
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.
Croatian: U bolesnika zaraženih HIV-om koji imaju tešku imunodeficijenciju u vrijeme započinjanja liječenja kombiniranom antiretrovirusnom terapijom (kART) može nastati upalna reakcija na asimptomatske ili rezidualne oportunističke patogene i prouzročiti ozbiljna klinička stanja ili pogoršanje simptoma.
English: When this is stably kept at undetectable levels, the chances that you can still pass on HIV to your sexual partners become negligible.
Croatian: Kada se ona stabilno održava na nemjerljivim razinama, vjerojatnost da virus HIV-a i dalje možete prenijeti na svoje seksualne partnere postaje zanemariva.
English: If you miss a dose of Trogarzo
Croatian: Ako propustite dozu lijeka Trogarzo
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion.
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju.
English: The subject had no adverse reactions associated with the positive immunogenicity result.
Croatian: Taj ispitanik nije imao nuspojave povezane s pozitivnim rezultatom na ispitivanju imunogenosti.
English: Store and transport refrigerated (2°C to 8°C).
Croatian: Čuvati i prevoziti na hladnom (2 °C do 8 °C).
English: 2 mL vial (Type I borosilicate glass) sealed with a stopper (butyl rubber) and an aluminum crimp cap.
Croatian: Bočica od 2 ml (borosilikatno staklo tipa I) zatvorena čepom (butilna guma) i aluminijskim prstenom.
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.
Croatian: Smanjena osjetljivost na ibalizumab ne mijenja osjetljivost na druge odobrene lijekove i ne rezultira selekcijom CD4-neovisnih virusnih izolata.
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.
Croatian: - Druge pomoćne tvari su saharoza, natrijev klorid (vidjeti odlomak 2. „Trogarzo sadrži malu količinu natrija”), polisorbat 80, histidin, kloridna kiselina, voda za injekcije.
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%).
Croatian: Najčešće prijavljene nuspojave bile su osip (9,2 %), proljev (3,9 %), omaglica (3,9 %), glavobolja
English: Passing HIV to others
Croatian: Prijenos HIV-a drugim osobama
English: • Functional monotherapy period (Day 7 to Day 13): All subjects received a 2,000 mg loading dose of ibalizumab on Day 7.
Croatian: • Razdoblje funkcionalne monoterapije (od 7. do 13. dana): Svi su ispitanici 7. dana dobili udarnu dozu ibalizumaba od 2000 mg.
English: What you need to know before you use Trogarzo
Croatian: Što morate znati prije nego što počnete primjenjivati Trogarzo
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.
Croatian: * Učestalost je izračunata na temelju podataka o sigurnosti primjene prikupljenih u razdoblju od 24 tjedna za 153 osobe uključene u TMB-202, ispitivanje faze 2b (n = 113) i TMB-301, ispitivanje faze 3 (n = 40), kao i podataka o sigurnosti primjene prikupljenih u razdoblju od najmanje 48 tjedana za 27 osoba iz ispitivanja TMB-301 koje su prešle u TMB-311, ispitivanje s proširenim pristupom.
English: • Remove the flip-off cap from the vial and wipe with an alcohol swab.
Croatian: • Uklonite „flip-off” kapicu s bočice i obrišite je alkoholnom maramicom.
English: Therapy should be initiated by a physician experienced in the management of HIV infection.
Croatian: Liječenje mora započeti liječnik s iskustvom u liječenju infekcije HIV-om.
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.
Croatian: U slučaju predoziranja, preporučuje se nadzor bolesnika kako bi se utvrdili bilo kakvi znakovi ili simptomi nuspojava i primijenilo odgovarajuće simptomatsko liječenje.
English: Other medicines and Trogarzo Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Headache, feeling dizzy, feeling sick (nausea) or feeling tired are common side effects of Trogarzo and can affect your ability to drive or use machines.
Croatian: Glavobolja, osjećaj omaglice, mučnina ili osjećaj umora česte su nuspojave lijeka Trogarzo i mogu utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
English: How to receive Trogarzo You will be given Trogarzo under the supervision of an experienced doctor or nurse.
Croatian: Lijek Trogarzo primat ćete pod nadzorom iskusnog liječnika ili medicinske sestre.
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.
Croatian: Nakon primjene ibalizumaba, pri klinički relevantnoj dozi od 800 do 2000 mg, vršna koncentracija u serumu (Cmax) povećavala se proporcionalno dozi, dok je povećanje područja ispod krivulje koncentracija-vrijeme (AUC) bilo veće od povećanja proporcionalnog dozi.
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.
Croatian: Rezultati fenotipskog i genotipskog testiranja nisu otkrili dokaze o unakrsnoj rezistenciji između ibalizumaba i bilo koje druge odobrene klase antiretrovirusnih lijekova.
English: (≥1/10); common (≥1/100 to < 1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000);
Croatian: Učestalost se određuje kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000),
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.
Croatian: Ispitivanje TNX-355.03 bilo je multicentrično, randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje sigurnosti i djelotvornosti s primjenom višekratnih doza i s tri skupine, provedeno na 82 ispitanika s infekcijom virusom HIV-1 koji nisu reagirali na visokoaktivnu antiretrovirusnu terapiju ili su imali terapijski neuspjeh.
English: Skin and subcutaneous tissue disorders rash**, dermatitis, dry skin
Croatian: Poremećaji kože i potkožnog tkiva osip**, dermatitis, suha koža
English: Genotoxicity and carcinogenicity studies have not been conducted.
Croatian: Genotoksičnost, kancerogeni potencijal Nisu provedena ispitivanja genotoksičnosti i kancerogenosti.
English: Specific metabolism studies were not conducted because ibalizumab is a protein.
Croatian: Posebna ispitivanja metabolizma nisu provedena jer je ibalizumab protein.
English: Uncommon (may affect up to 1 in 100 people):
Croatian: Često (mogu se javiti u do 1 na 10 osoba):
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.
Croatian: Od 16. tjedna bolesnici u skupini koja je primala placebo koji su doživjeli virološki neuspjeh imali su mogućnost otvorenog primanja 15 mg/kg ibalizumaba svaka dva tjedna i/ili prelaska na novi OBR.
English: abnormal results on tests of the heart's electrical activity (electrocardiogram)
Croatian: Vidljivo u nalazima: • odstupanja u rezultatima pretrage električne aktivnosti srca (EKG - elektrokardiogram)
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.
Croatian: Ispitanici su prethodno bili izloženi intenzivnom liječenju: prije no što su pristupili ispitivanju, 53 % sudionika liječeno je s 10 ili više antiretrovirotika; 98 % ih je liječeno nukleozidnim inhibitorima reverzne transkriptaze (NRTI), 98 % inhibitorima proteaze (PI), 80 % nenukleozidnim inhibitorima reverzne transkriptaze (NNRTI), 78 % inhibitorima prijenosa lanca integraze (INSTI), 30 % inhibitorima fuzije gp41 i 20 % antagonistima koreceptora CCR5.
English: • Discard partially used vials or empty vials of ibalizumab and any unused portion of the diluted ibalizumab solution in accordance with local requirements.
Croatian: • Bacite djelomično upotrijebljene ili prazne bočice ibalizumaba i sav neiskorišten dio razrijeđene otopine ibalizumaba sukladno nacionalnim propisima.
English: Description of selected adverse reactions
Croatian: Opis odabranih nuspojava Osip
English: Common dry mouth
Croatian: Često suha usta
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.
Croatian: Ako se ne primijeni odmah, razrijeđenu otopinu ibalizumaba čuvajte na temperaturi ispod 25 °C do četiri sata ili u hladnjaku (2 °C do 8 °C) do 24 sata.
English: Ibalizumab has a minor influence on the ability to drive and use machines.
Croatian: Ibalizumab malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
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.
Croatian: Kako bi se dodatno definirala djelotvornost ibalizumaba u kombinaciji s drugim antiretrovirusnim lijekovima, za liječenje odraslih osoba zaraženih multirezistentnim virusom HIV-1 u kojih inače nije moguće složiti režim supresivnog antivirusnog liječenja, nositelj odobrenja za stavljanje lijeka u promet mora provesti i dostaviti rezultate ispitivanja na temelju podataka iz registra lijekova.
English: This period was to establish the virologic activity of ibalizumab.
Croatian: Svrha ovog razdoblja bila je utvrditi virološku aktivnost ibalizumaba.
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.
Croatian: Od 153 ispitanika, dva ispitanika razvila su upalni sindrom imunosne rekonstitucije (IRIS; vidjeti dio 4.4) koji se manifestirao kao pogoršanje progresivne multifokalne leukoencefalopatije (ocijenjeno kao ozbiljno) odnosno kriptokokne kožne infekcije (ocijenjeno kao ozbiljno).
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.
Croatian: Ako se nisu pojavile nuspojave povezane s infuzijom, trajanje naknadnih infuzija (doze održavanja) može se smanjiti, ali ne smije biti kraće od 15 minuta.
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).
Croatian: Većina ispitanika u ispitivanju TMB-301 bili su muškarci (85 %), bijelci (55 %) i između 23 i 65
English: • Once diluted, the ibalizumab solution should be administered immediately.
Croatian: • Nakon razrjeđivanja, otopina ibalizumaba treba se odmah primijeniti.
English: Loading dose of 2,000 mg
Croatian: Udarna doza od 2000 mg
English: • Insert sterile syringe needle into the vial through the center of the stopper and withdraw 1.33 mL from each vial (NOTE: a small residual amount may remain in the vial, discard unused portion) and transfer into a 250 mL intravenous bag of sodium chloride 9 mg/mL (0.9%) solution for injection.
Croatian: • Umetnite sterilnu iglu štrcaljke u bočicu kroz sredinu čepa i povucite 1,33 ml iz svake bočice (NAPOMENA: u bočici može preostati mala količina lijeka, bacite neiskorišteni dio) te uštrcajte u infuzijsku vrećicu s 250 ml 0,9 %-tne otopine natrijeva klorida za injekciju (9 mg/ml).
English: Such non-linear effects in clearance are common for monoclonal antibodies targeting cell surface molecules, such as CD4.
Croatian: Takvi nelinearni učinci u klirensu uobičajeni su za monoklonska antitijela koja djeluju na molekule na površini stanice kao što je CD4.
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
Croatian: - ako ste alergični na ibalizumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Beginning at Day 21, an 800 mg maintenance dose of ibalizumab was administered every two weeks through Week 25.
Croatian: Počevši od 21. dana, doza održavanja od 800 mg ibalizumaba primjenjivana je svaka dva tjedna do 25. tjedna.
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.
Croatian: Povišenja razine kreatinina 3. stupnja često su se javljala u ispitanika s podležećom bolešću bubrega, čimbenicima rizika za bolest bubrega i/ili u ispitanika koji su istodobno uzimali lijekove poznate kao nefrotoksične.
English: How you will be given Trogarzo The drip (infusion) will be given into a vein over 15 to 30 minutes.
Croatian: Infuzija (drip) primijenit će se u venu u trajanju od 15 do 30 minuta.
English: The safety and efficacy of ibalizumab in geriatric patients (≥ 65 years of age) have not been established.
Croatian: Sigurnost i djelotvornost ibalizumaba u gerijatrijskih bolesnika (≥ 65 godina) nisu ustanovljene.
English: This is because Trogarzo has not been studied in this age group.
Croatian: To je stoga jer nije provedeno ispitivanja lijeka Trogarzo u toj dobnoj skupini.
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Croatian: Potrebno je provjeriti sve upalne simptome i po potrebi uvesti liječenje.
English: Trogarzo is used in adults to treat HIV infection that has not responded to a number of HIV treatments in the past.
Croatian: Trogarzo se primjenjuje u odraslih osoba za liječenje infekcije virusom HIV-a koja nije reagirala na više prethodno provedenih terapija.
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.
Croatian: Kako bi se izbjeglo prenošenje HIV-a na novorođenče, preporučuje se da žene zaražene HIV-om ne doje ni pod kojim uvjetima.
English: Virologic response CD4 cell counts (cells/ mm3)
Croatian: Virološki odgovor Broj CD4 stanica (stanica/mm
English: It belongs to a group of medicines called ‘antiretrovirals'.
Croatian: Pripada skupini lijekova koji se zovu „antiretrovirusni lijekovi (antiretrovirotici)”.
English: The results of the primary endpoint analysis are shown in Table 2 below.
Croatian: Rezultati analize primarne mjere ishoda prikazani su u tablici 2 u nastavku.
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.
Croatian: Ako se propusti doza održavanja ibalizumabom (800 mg) za tri dana ili dulje nakon predviđenog dana doziranja, treba što je prije moguće primijeniti udarnu dozu (2000 mg).