natgillin/translations-raw huggingface dataset:
This study should be conducted according to an agreed protocol.
Študijo je treba izvesti v skladu z dogovorjenim protokolom.
→ Talk to your doctor immediately.
→ Takoj se posvetujte z zdravnikom.
Typically, such reactions have been observed within the first few weeks or months of initiation of cART.
Take reakcije so navadno opazili v prvih nekaj tednih ali mesecih po uvedbi cART.
The trial was composed of three discrete periods:
Preskušanje je potekalo v treh ločenih obdobjih:
Do not give this medicine to children and adolescents below 18 years of age.
Tega zdravila ne smete dajati otrokom in mladostnikom, mlajšim od 18 let.
Results are similar to the adult population (≥18 to 65 years of age), however no definite conclusions can be drawn.
Rezultati so podobni kot pri odraslem prebivalstvu (≥ 18 do 65 let), vendar dokončnih zaključkov ni mogoče oblikovati.
Precautions to prevent transmission should be taken in accordance with national guidelines.
Previdnostni ukrepi za preprečevanje prenosa morajo biti v skladu z nacionalnimi smernicami.
This is less likely if you receive Trogarzo regularly and without gaps in treatment.
To je manj verjetno, če zdravilo Trogarzo prejemate redno in brez vrzeli v zdravljenju.
Frequencies are defined as very common
Pogostnost je opredeljena kot: zelo pogosti
95% CI*
95-% IZ*
The relevance of this effect for human pregnancy and lactation remains unknown.
Pomen tega učinka na nosečnost in dojenje pri ljudeh še ni znan.
Toxicity to reproduction and development
Toksičnost za razmnoževanje in razvoj
• It is very important that you are given Trogarzo every 2 weeks as instructed by your doctor.
• Zelo pomembno je, da zdravilo Trogarzo prejmete vsaka dva tedna po navodilih zdravnika.
Trial TMB-301
Preskušanje TMB-301
Trial TNX-355.03
Preskušanje TNX-355.03
Patients in all three arms also received an OBR.
Bolniki vseh treh skupin so prejeli tudi OBR.
Date of first authorisation: {DD month YYYY}
Datum prve odobritve: {DD. mesec LLLL}
ATC code: J05AX23
Oznaka ATC: J05AX23
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
V primeru pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
Resistance With INSTI resistance Without INSTI resistance OSS
odpornost z odpornostjo proti INSTI brez odpornosti proti INSTI OSS
Your immune system might get stronger and begin to fight infections that have been hidden in your body for a long time (this is called ‘immune reconstitution inflammatory syndrome').
Vaš imunski sistem se lahko okrepi in se začne boriti proti okužbam, ki so bile dolgo časa prikrite v vašem telesu (to imenujemo „vnetni sindrom imunske obnove“ ).
• If you miss an appointment, ask your doctor straight away when to schedule your next dose.
• Če zamudite termin, se nemudoma posvetujte z zdravnikom, kdaj načrtovati naslednji odmerek.
Standard supportive measures should be applied as required, including monitoring of vital signs as well as observation of the clinical status of the patient.
Po potrebi je treba izvajati standardne podporne ukrepe, vključno s spremljanjem življenjskih znakov in opazovanjem kliničnega stanja bolnika.
The elimination is nonlinear and concentration-dependent.
Izločanje je nelinearno in odvisno od koncentracije.
The use of an investigational drug as a component of the optimized background regimen was allowed.
Uporaba preiskovanega zdravila kot sestavnega dela optimizirane osnovne sheme je bila dovoljena.
4 vials (5.32 mL)
4 viale (5,32 ml)
This will reduce the amount of virus in your body, and keeps it at a low level.
To zmanjša količino virusa HIV v vašem telesu in ga ohranja na nizki ravni.
MARKETING AUTHORISATION NUMBER(S) EU/1/19/1359/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/19/1359/001
This is because Trogarzo has not been studied in this age group.
Razlog za to je, da zdravilo Trogarzo v tej starostni skupini ni bilo preučeno.
10 vials (13.3 mL)
10 vial (13,3 ml)
It is recommended that women of childbearing potential use an effective method of contraception during treatment.
Priporočljivo je, da ženske v rodni dobi med zdravljenjem uporabljajo učinkovito kontracepcijo.
{DD month YYYY}
{DD. mesec LLLL}
CD4 cells are a type of white blood cell that are important in helping your body to fight infection.
Celice CD4 so vrsta belih krvnih celic, ki pomembno pomagajo vašemu telesu pri boju proti okužbam.
End of control period End of functional monotherapy period
konec obdobja nadzorovanja konec obdobja funkcionalne monoterapije
Ibalizumab is active against HIV-1 group M isolates (subtypes A, B, C, D, E, or O).
Ibalizumab je aktiven proti izolatom virusa HIV-1 iz skupine M (podtipi A, B, C, D, E ali O).
When this is stably kept at undetectable levels, the chances that you can still pass on HIV to your sexual partners become negligible.
Če se ta stabilno ohranja na nezaznavnih ravneh, postanejo možnosti, da še vedno prenesete HIV na svoje spolne partnerje, zanemarljive.
Marketing Authorisation Holder and manufacturer Theratechnologies International Limited 10 Earlsfort Terrace,
Imetnik dovoljenja za promet z zdravilom in proizvajalec Theratechnologies International Limited 10 Earlsfort Terrace,
Patients in Arm A and B arm who experienced virologic failure had the option of switching to a new OBR.
Bolniki v skupinah A in B, ki so doživeli virološki neuspeh, so imeli možnost prehoda na novo OBR.
If you stop and there is a gap in your treatment, the level of HIV virus in your blood may begin to rise.
Če prenehate in v vašem zdravljenju pride do vrzeli, se lahko raven virusa HIV v vaši krvi začne povečevati.
This is a type of protein called a ‘monoclonal antibody' that can attach to a specific target in the body.
To je vrsta beljakovine, imenovana „monoklonsko protitelo“, ki se lahko veže na specifično mesto v telesu.
Demonstrating drug susceptibility by both genotypic and phenotypic testing was required, when testing by both methods was technically feasible.
Občutljivost zdravila je bilo treba dokazati z genotipskim in fenotipskim testiranjem, če je bilo preskušanje z obema metodama tehnično izvedljivo.
The body weight range was very narrow in the population PK model, and the impact of body weight may not be precisely estimated.
Razpon telesne mase je bil pri modelu populacijske farmakokinetike zelo ozek in vpliv telesne mase morda ni natančno ocenjen.
This medicine reduces the amount of HIV in your body.
To zdravilo zmanjša količino virusa HIV v vašem telesu.
Do not change the schedule of your Trogarzo infusions or any of your other antiretroviral medicines without talking to your doctor first.
• Ne spreminjajte urnika svojih infuzij zdravila Trogarzo ali drugih protiretrovirusnih zdravil, ne da bi se najprej posvetovali z zdravnikom.
The HIV virus infects cells in your blood called ‘CD4' or ‘T-cells'.
Virus HIV okuži celice v vaši krvi, imenovane „CD4“ ali „T-celice“.
A pre- and post-natal developmental study was performed in cynomolgus monkeys.
Pred- in postnatalna razvojna študija je bila izvedena na opicah vrste cynomolgus.
This behaviour is characteristic of saturable (capacity-limited) elimination kinetics.
To obnašanje je značilno za kinetiko nasičenega (s kapaciteto omejenega) izločanja.
Subjects must have been treated with antiretrovirals for at least 6 months and be failing or had recently failed therapy (i.e., in the last 8 weeks).
Preiskovanci so se morali vsaj 6 mesecev neuspešno zdraviti s protiretrovirusnimi zdravili ali pa so morali biti neuspešno zdravljeni pred kratkim (tj. v zadnjih 8 tednih).
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.
Znano je, da se humani IgG prve dni po rojstvu izloča v materino mleko, njegova koncentracija pa se kmalu za tem zniža; zato v tem kratkem obdobju ni mogoče izključiti tveganja za dojenega otroka in se ibalizumab med dojenjem ne sme uporabljati.
Do not drive or use machines after you have been given Trogarzo if you do not feel well enough.
Ne vozite in ne upravljajte strojev, če se po prejetju zdravila Trogarzo ne počutite dovolj dobro.
If a reaction occurs, the infusion should be discontinued and appropriate medical therapies should be administered.
Če pride do reakcije, je treba infuzijo prekiniti in zagotoviti ustrezno zdravljenje.
This dose was administered as it is at least 10-fold the estimated free clinical AUC and Cmax for the 800 mg Q2W dose.
Ta odmerek je bil uporabljen, ker je vsaj 10-krat večji od ocenjene proste klinične AUC in Cmax za odmerek 800 mg Q2W.
Patients experiencing these symptoms should be advised to use caution when driving or using machines until symptoms abate.
pri katerih se pojavijo ti simptomi, je treba svetovati, naj bodo previdni pri vožnji ali uporabi strojev, dokler se simptomi ne ublažijo.
How you will be given Trogarzo The drip (infusion) will be given into a vein over 15 to 30 minutes.
Kako vam bodo dajali zdravilo Trogarzo Kapalno infuzijo (infuzijo) boste prejemali v veno 15-30 minut.
* The OSS indicates the number of fully active drugs in a subject's Optimized Background Regimen (OBR) based on both current and available historical resistance test results.
* OSS (Overall Susceptibility Score) označuje število popolnoma aktivnih zdravil v preiskovančevi optimizirani osnovni shemi (OBR - Optimized Background Regimen), ki temelji na trenutnih in razpoložljivih preteklih rezultatih testa odpornosti.
Maintenance dose of 800 mg
vzdrževalni odmerek 800 mg
If you are not sure, talk to your doctor or nurse before being given Trogarzo.
Če ste negotovi, se posvetujte z zdravnikom ali medicinsko sestro, preden prejmete zdravilo Trogarzo.
Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki na viali in škatli poleg oznake „EXP“.
However, the effect is unlikely to impact virologic outcome and does not warrant a dose adjustment.
Ta učinek pa verjetno ne bo vplival na virološki izid, zato prilagoditev odmerka ni potrebna.
Trogarzo is used in combination with other medicines.
Zdravilo Trogarzo se uporablja v kombinaciji z drugimi zdravili.
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).
Večina preiskovancev v preskušanju TMB-301 je bila moških (85 %), belcev (55 %) in starih od 23 do 65 let (povprečna [SD] starost: 50,5 [11,0] leta).
This period was to establish the safety and durability of virologic suppression of ibalizumab when used in combination with an optimized background regimen.
To obdobje je bilo namenjeno ugotavljanju varnosti in trajnosti virološke supresije ibalizumaba, kadar se uporablja v kombinaciji z optimizirano osnovno shemo.
The subject had no adverse reactions associated with the positive immunogenicity result.
Preiskovanec ni imel neželenih učinkov, povezanih s pozitivnim rezultatom glede imunogenosti.
While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Čeprav je bilo dokazano, da učinkovito preprečevanje virusnih okužb s protiretrovirusnim zdravljenjem bistveno zmanjša tveganje spolnega prenosa, manjšega preostalega tveganja ni mogoče izključiti.
abnormal results on tests of the heart's electrical activity (electrocardiogram)
• nenormalni rezultati pri preiskavah električne aktivnosti srca (elektrokardiogramu)
Trogarzo is used in adults to treat HIV infection that has not responded to a number of HIV treatments in the past.
Zdravilo Trogarzo se pri odraslih uporablja za zdravljenje okužbe z virusom HIV, ki se v preteklosti ni odzvala na številne oblike zdravljenja HIV.
This helps your body to increase the CD4 cell count in your blood.
To pomaga vašemu telesu povečati število celic CD4 v krvi.
Women who are HIV-positive must not breast feed because HIV infection can be passed on to the baby in breast milk.
Ženske, ki so okužene z virusom HIV, ne smejo dojiti, ker se okužba z virusom lahko prenese na otroka z materinim mlekom.
HIV-RNA (copies/mL)
HIV-RNK (kopije/ml)
Allergic reaction (hypersensivity).
• Alergijska reakcija (preobčutljivost)
It is also active against HIV-1 resistant to currently approved antiretroviral medicinal products and exhibits antiretroviral activity against R5-tropic, X4-tropic, and dual-tropic HIV-1.
Aktiven je tudi proti virusu HIV-1, odpornemu proti trenutno odobrenim protiretrovirusnim zdravilom, in ima protiretrovirusno delovanje proti R5-tropnim, X4-tropnim in dvojno tropnim virusom HIV-1.
MIAS Pharma Limited Suite 2 Stafford House, Strand Road, Portmarnock, Co. Dublin, D13 H525 Ireland
MIAS Pharma Limited Suite 2 Stafford House, Strand Road, Portmarnock, Co. Dublin, D13 H525 Irska
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.
Če lečeči zdravnik ugotovi, da za bolnika ni nobene dodatne klinične koristi v smislu zmanjšanja virusne obremenitve, je treba razmisliti o možnosti prenehanja zdravljenja z ibalizumabom, glejte oddelek 5.1.
More than one vial of Trogarzo will be needed to get the required dose.
Za zahtevani odmerek bo potrebna več kot ena viala zdravila Trogarzo.
• 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.
• 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.
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.
Nosečnost Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom,
The duration of the first infusion (loading dose) should be no less than 30 minutes.
Trajanje prve infuzije (polnilni odmerek) ne sme biti krajše od 30 minut.
It is unknown if Trogarzo can pass into breast milk.
Ni znano, ali lahko zdravilo Trogarzo prehaja v materino mleko.
Pharmacotherapeutic group: Antivirals for systemic use, other antivirals.
Farmakoterapevtska skupina: protivirusna zdravila za sistemsko uporabo, druga protivirusna zdravila.
• Discard partially used vials or empty vials of ibalizumab and any unused portion of the diluted ibalizumab solution in accordance with local requirements.
• Delno uporabljene viale ali prazne viale ibalizumaba in vsakršen neporabljen del razredčene raztopine ibalizumaba zavrzite v skladu z lokalnimi predpisi.
What you need to know before you use Trogarzo 3.
Kaj morate vedeti, preden boste uporabili zdravilo Trogarzo 3.
• 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.
• 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.
WuXi Biologics Co, Ltd 108 Meiliang Road, MaShan Binhu District, Wuxi, 214092, China
Wuxi Biologics Co, Ltd 108 Meiliang Road, MaShan Binhu District, Wuxi Jiangsu, 214092, Kitajska
The volume of distribution of ibalizumab is approximately 4.8 L, which is comparable with vascular space, based on the performed population pharmacokinetics analysis.
Volumen porazdelitve ibalizumaba je približno 4,8 l, kar je na podlagi opravljene farmakokinetične analize populacije primerljivo z vaskularnim prostorom.
Rashes were common.
Izpuščaji so bili pogosti.
This leaflet was last revised in month YYYY.
Navodilo je bilo nazadnje revidirano mesec LLLL.
Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Študije vpliva na sposobnost razmnoževanja na živalih niso zadostne (glejte poglavje 5.3).
The subject received ibalizumab therapy for an additional 1.5 years before discontinuing voluntarily with an undetectable viral load (<50 copies/mL).
Preiskovanec je prejemal zdravljenje z ibalizumabom dodatnega 1,5 leta, preden je prostovoljno prekinil zdravljenje ob nezaznavni virusni obremenitvi (< 50 kopij/ml).
Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and pneumocystis jiroveci pneumonia.
Relevantni primeri so citomegalovirusni retinitis, generalizirane in/ali žariščne okužbe z mikobakterijami in s Pneumocystis jiroveci povzročena pljučnica.
The results suggest that ibalizumab concentration decreases as body weight increases.
Rezultati kažejo, da se koncentracije ibalizumaba s povečanjem telesne mase znižajo.
Hydrochloric acid (for pH-adjustment) Water for injections
Klorovodikova kislina (za prilagoditev pH) Voda za injekcije
Virologic response CD4 cell counts (cells/ mm3)
virološki odziv število celic CD4 (celice/mm3)
How to receive Trogarzo You will be given Trogarzo under the supervision of an experienced doctor or nurse.
Zdravilo Trogarzo boste prejeli pod nadzorom izkušenega zdravnika ali medicinske sestre.
Ibalizumab is expected to degrade to small peptides and individual amino acids.
Ibalizumab naj bi se razgradil na majhne peptide in posamezne aminokisline.
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).
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).
- The other excipients are sucrose, sodium chloride (see section 2 ‘Trogarzo has a low sodium content'), polysorbate 80, histidine, hydrochloric acid, water for injections.
- Druge sestavine zdravila so saharoza, natrijev klorid (glejte poglavje 2 „Zdravilo Trogarzo ima nizko vsebnost natrija“), polisorbat 80, histidin, klorovodikova kislina, voda za injekcije.
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).
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).
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.
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.
Pack of 2 vials.
Pakiranje vsebuje 2 viali.
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.
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.
• itchy skin, or skin damage bruising abnormal heartbeat high blood pressure or frequent changes in blood pressure Seen in tests:
• povišan krvni tlak ali pogoste spremembe krvnega tlaka Opaženi pri preiskavah:
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.
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).
Common (may affect up to 1 in 10 people): skin rash
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): • kožni izpuščaj
Prophylactic medication is not warranted prior to each infusion.
Profilaktično zdravljenje pred vsakim infundiranjem ni potrebno.
Colourless to slightly yellow, clear to slightly opalescent aqueous solution.
Brezbarvna do rahlo rumena, bistra do rahlo opalescentna vodna raztopina.
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.
V primeru prevelikega odmerjanja se priporoča spremljanje bolnika za morebitne znake ali simptome neželenih učinkov in ustrezno simptomatsko zdravljenje.
Your doctor has prescribed Trogarzo to help control your HIV infection.
Zdravnik vam je predpisal zdravilo Trogarzo za pomoč pri obvladovanju okužbe z virusom HIV.
As an example, an OSS of 2 would indicate that the HIV-1 isolate tested was fully susceptible to two drugs in the OBR.
Na primer, OSS 2 kaže, da je testirani izolat HIV-1 popolnoma dovzeten za dve zdravili v OBR.
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.
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.
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).
V primeru izpuščajev je priporočljivo bolnika spremljati in po potrebi začeti simptomatsko zdravljenje (npr. kortikosteroidi in/ali antihistaminiki).
• feeling dizzy, faint or light headed when standing up
• občutek omotice, omedlevice ali šibkosti pri vstajanju
Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for developmental effects was 110 mg/kg.
Pod pogoji te študije je bila raven brez brez opaženih negativnih učinkov (NOAEL) na razvoj 110 mg/kg.
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.
Opravljena je bila populacijska farmakokinetična analiza, da bi raziskali možne učinke izbranih sospremenljivk (starost, telesna masa, spol, izhodiščno število celic CD4+) na farmakokinetiko ibalizumaba.
IRIS was reported in 2 subjects out of 153 treated with ibalizumab in Phase 2b and 3 clinical studies (see section 4.8).
O VSIO so poročali pri 2 od 153 oseb, zdravljenih z ibalizumabom v 2.b in 3. fazi kliničnih študij (glejte poglavje 4.8).
Loading dose of 2,000 mg
polnilni odmerek 2.000 mg