natgillin/translations-raw huggingface dataset:
(≥1/10); common (≥1/100 to < 1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000);
(≥ 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).
Virologic response at week 25 by baseline CD4 cell count, integrase inhibitor resistance and Overall Susceptibility Score (OSS)* for study TMB-301
Virološki odziv v 25. tednu glede na izhodiščno število celic CD4, odpornost proti zaviralcem integraze in skupno oceno občutljivosti (OSS)* za študijo TMB-301
The safety and efficacy of ibalizumab in children under the age of 18 years have not yet been established.
Varnost in učinkovitost ibalizumaba pri otrocih in mladostnikih, starih manj kot 18 let, še nista bili dokazani.
This period was to establish the virologic activity of ibalizumab.
To obdobje naj bi vzpostavilo virološko aktivnost ibalizumaba.
The results of the primary endpoint analysis are shown in Table 2 below.
Rezultati analize primarnih opazovanih dogodkov so prikazani v preglednici 2.
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.
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.
Trogarzo has a low sodium content
Zdravilo Trogarzo ima nizko vsebnost natrija
Ibalizumab concentrate for solution for infusion should be prepared by a healthcare professional using aseptic technique as follows:
Koncentrat ibalizumaba za raztopino za infundiranje mora pripraviti zdravstveni delavec z aseptično tehniko, kot sledi:
Such non-linear effects in clearance are common for monoclonal antibodies targeting cell surface molecules, such as CD4.
Takšni nelinearni učinki, kar zadeva očistek, so običajni za monoklonska protitelesa, usmerjena proti molekulam na celični površini, kot je CD4.
• Functional monotherapy period (Day 7 to Day 13): All subjects received a 2,000 mg loading dose of ibalizumab on Day 7.
• Obdobje funkcionalne monoterapije (od 7. do 13. dne): Vsi preiskovanci so na 7. dan prejeli 2.000 mg ibalizumaba kot polnilni odmerek.
Phenotypic and genotypic test results revealed no evidence of cross-resistance between ibalizumab and any of the approved classes of anti-retroviral medicinal products.
Rezultati fenotipskih in genotipskih testov niso pokazali navzkrižne odpornosti med ibalizumabom in katerim koli odobrenim skupinam protiretrovirusnih zdravil.
Decreased susceptibility to ibalizumab does not alter susceptibility to other approved agents and does not result in the selection of CD4-independent viral isolates.
Zmanjšana dovzetnost za ibalizumab ne spremeni občutljivosti za druge odobrene učinkovine in ne povzroči selekcije virusnih izolatov, neodvisnih od CD4.
Keep the vial in the outer carton in order to protect from light.
Vialo shranjujte v zunanji škatli za zagotovitev zaščite pred svetlobo.
Your doctor or nurse will monitor you during the Trogarzo infusion and for a period of time after your infusion.
Zdravnik ali medicinska sestra vas bosta med infuzijo zdravila Trogarzo in še nekaj časa po njej opazovala.
Ibalizumab was generally well tolerated in pregnant monkeys and in their offspring, when evaluated through 180 ± 2 days postpartum.
Ibalizumab so breje opice in njihovi potomci na splošno dobro prenašali; ocenjevali so jih v 180 dni ± 2 dneva po porodu.
Decreased susceptibility to ibalizumab was a finding in the majority of patients who experienced virologic failure up to week 24 in the pivotal study.
Zmanjšana dovzetnost za ibalizumab je bila ugotovljena pri večini bolnikov, pri katerih je do 24. tedna prišlo do virološkega neuspeha v ključni študiji.
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.
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.
If you are breast-feeding, or thinking about breast-feeding:
Če dojite ali razmišljate, da bi dojili:
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.
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.
If you stop having Trogarzo Keep having Trogarzo infusions until your doctor tells you to stop.
Prejemanje infuzij zdravila Trogarzo nadaljujte, dokler vam zdravnik ne naroči, da prenehajte.
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.
(seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
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.
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.
What Trogarzo is and what it is used for 2.
Kaj je zdravilo Trogarzo in za kaj ga uporabljamo 2.
You can still pass on HIV when taking this medicine, if you have detectable levels of HIV in your body.
Ko jemljete to zdravilo, lahko virus HIV še vedno prenesete, če imate v telesu zaznavne ravni virusa HIV.
Ibalizumab is produced in murine myeloma non-secreting (NS0) cells by recombinant DNA technology.
Ibalizumab se proizvaja v nesekrecijskih (NS0) celicah murinskega mieloma s pomočjo tehnologije rekombinantne DNK.
No action was taken with ibalizumab in response to these events.
V odgovor na te dogodke niso bili izvedeni nobeni ukrepi, kar zadeva ibalizumab.
Ibalizumab pharmacokinetics in geriatric patients (≥ 65 years of age) is limited (n = 5).
Starejša populacija Podatkov o farmakokinetiki ibalizumaba pri geriatričnih bolnikih (≥ 65 let) je malo (n = 5).
The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Imetnik dovoljenja za promet z zdravilom mora prvo PSUR za to zdravilo predložiti v 6 mesecih po pridobitvi dovoljenja za promet.
Instructions on dilution of ibalizumab before use
Navodila za redčenje ibalizumaba pred uporabo
• Remove the flip-off cap from the vial and wipe with an alcohol swab.
• Odstranite snemno zaporko z viale in vialo obrišite z alkoholnim zložencem.
Trogarzo attaches to the CD4 receptor and blocks HIV from entering and infecting your blood cells.
Zdravilo Trogarzo se veže na receptor CD4 in virusu HIV prepreči vstop in okuženje krvnih celic.
Genotoxicity and carcinogenicity studies have not been conducted.
Genotoksičnost, rakotvorni potencial Študij genotoksičnosti in rakotvornosti niso izvedli.
Store in a refrigerator (2°C to 8°C).
Shranjujte v hladilniku (2-8 °C).
This was an observational period to establish baseline HIV viral load.
To je bilo opazovalno obdobje za določitev izhodiščne virusne obremenitve z virusom HI.V.
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.
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.
It will be used together with other HIV medicines called ‘antiretrovirals'.
Uporabljalo se bo skupaj z drugimi zdravili za zdravljenje okužbe z virusom HIV, imenovanimi „protiretrovirusna zdravila“.
If the patient does not experience an infusion-associated adverse reaction, the post-infusion observation time can be reduced to 15 minutes thereafter.
Če se pri bolniku ne pojavijo neželeni učinki, povezani z infuzijo, se lahko čas opazovanja po infuziji skrajša na 15 minut.
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.
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.
Specific metabolism studies were not conducted because ibalizumab is a protein.
Specifičnih študij presnove niso opravili, ker je ibalizumab beljakovina.
Epitope mapping studies indicate that ibalizumab binds to a conformational epitope located primarily in domain 2 of the extracellular portion of the CD4 receptor.
Študije kartiranja epitopa kažejo, da se ibalizumab veže na konformacijski epitop, ki se nahaja predvsem na domeni 2 izvenceličnega dela receptorja CD4.
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.
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.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 200 mg
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 200 mg
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.
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.
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.
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.
You must not be given Trogarzo: - if you are allergic to ibalizumab or any of the other ingredients of this medicine (listed in section
- če ste alergični na ibalizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Ibalizumab, a humanized monoclonal antibody of immunoglobulin G type 4 (IgG4), is a CD4 domain 2-directed HIV-1 inhibitor.
Mehanizem delovanja Ibalizumab, humanizirano monoklonsko protitelo imunoglobulin G tipa 4 (IgG4), je zaviralec HIV-1,
Ibalizumab was administered to pregnant females at a 110mg/kg weekly dose from gestation Day 20-22 until parturition (approximately 22 doses/animal).
Ibalizumab so dajali brejim samicam v tedenskem odmerku 110 mg/kg od 20. do 22. dneva gestacije do poroda (približno 22 odmerkov/žival).
Out of the 153 subjects in Phase 2b and 3 clinical studies, one subject experienced a severe rash (non-serious).
Izmed 153 preiskovancev v 2.b in 3. fazi kliničnih študij je en preiskovanec imel hud kožni izpuščaj (ki ni bil resen).
What Trogarzo looks like and contents of the pack Trogarzo is a colourless to slightly yellow, clear to slightly opalescent concentrate for solution for infusion (sterile concentrate), with no visible particles.
Zdravilo Trogarzo je brezbarven do rahlo rumen, bister do rahlo opalescenten koncentrat za raztopino za infundiranje (sterilen koncentrat) brez vidnih delcev.
Ibalizumab administered as a single agent exhibits nonlinear pharmacokinetics at a dose range of 0.3-25 mg/kg.
Ibalizumab, uporabljen kot samostojno zdravilo, kaže nelinearno farmakokinetiko v razponu odmerkov 0,3-25 mg/kg.
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.
Izmed 153 preiskovancev se je pri dveh preiskovancih razvil vnetni sindrom imunske obnove (VSIO; glejte poglavje 4.4), ki se je pokazal kot eksacerbacija progresivne multifokalne levkoencefalopatije (resne) in kot eksacerbacija kriptokokne kožne infekcije (resne).
Trogarzo is used in combination with other medicines called ‘antiretrovirals'.
Zdravilo Trogarzo se uporablja v kombinaciji z drugimi zdravili, imenovanimi „protiretrovirusna zdravila“.
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%).
(3,9 %), glavobol (3,9 %), navzea (3,9 %), utrujenost (2,0 %) in bruhanje (2,0 %).
Proportion of subjects achieving a ≥ 0.5 log10
Delež preiskovancev, ki so dosegli zmanjšanje virusne obremenitve za ≥ 0,5 log10
Immune reconstitution inflammatory syndrome (IRIS)
Vnetni sindrom imunske obnove (VSIO)
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.
Ibalizumab preprečuje, da bi virus HIV-1 okužil celice CD4+ T, tako da se veže na domeno 2 CD4 in ovira korake po pritrditvi, ki so potrebni za vstop delcev virusa HIV-1 v gostiteljske celice, in preprečuje prenos virusa prek fuzije celic.
There are no data from the use of ibalizumab in pregnant women.
Podatkov o uporabi ibalizumaba pri nosečnicah ni.
Ibalizumab is not recommended during pregnancy.
Ibalizumab v nosečnosti ni priporočljiv.
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.
Pri večini preiskovancev, pri katerih je prišlo do virološkega neuspeha, so opažali zmanjšano dovzetnost za ibalizumab, ki je opredeljena kot zmanjšanje največjega deleža inhibicije (Maximum Percent Inhibition - MPI) in je lahko povezana z genotipskimi spremembami v sekvenci, ki kodira ovojnico HIV-1, kar povzroči izgubo potencialnih N-glikozilacijskih mest (potential N-linked glycosylation sites - PNGS) v zanki V5 gp120.
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVAJALCI BIOLOŠKE UČINKOVINE IN PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ
Human immunoglobulin (IgG) is known to cross the placental barrier.
Znano je, da humani imunoglobulin (IgG) prehaja placentno pregrado.
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.
1.000 kopij/ml in dokumentirano odpornost proti vsaj enemu protiretrovirusnemu zdravilu iz treh skupin protiretrovirusnih zdravil, izmerjeno s testiranjem odpornosti.
Trogarzo can cause serious side effects that you need to tell your doctor or nurse about straight away.
Bodite pozorni na neželene učinke Zdravilo Trogarzo lahko povzroči resne neželene učinke, o katerih morate nemudoma obvestiti zdravnika ali medicinsko sestro.
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.
Če ste zdravilo hranili v hladilniku, pustite razredčeno raztopino ibalizumaba na sobni temperaturi (20-25 °C) vsaj 30 minut, vendar ne več kot 4 ure, preden daste zdravilo.
* 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.
TMB-202 (n = 113) in 3. fazo študije TMB-301 (n = 40), ter vsaj 48 tednov varnostnih podatkov 27 preiskovancev iz študije TMB-301, ki so bili preusmerjeni v razširjeno študijo dostopa TMB-311.
After the infusion is complete, flush with 30 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
Po zaključku infuzije izperite s 30 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
Elderly population
Starejše osebe
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.
Če razredčene raztopine ibalizumaba ne daste takoj, jo hranite pri temperaturi do 25 °C do 4 ure ali v hladilniku (2-8 °C) do 24 ur.
Beginning at Day 21, an 800 mg maintenance dose of ibalizumab was administered every two weeks through Week 25.
Od 21. dne dalje se je vzdrževalni odmerek 800 mg ibalizumaba dajal vsaka dva tedna do 25. tedna.
Theratechnologies International Limited 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland Tel: + 35319201427 regulatoryaffairs@theratech.com
Theratechnologies International Limited 10 Earlsfort Terrace, Dublin 2, D02 T380, Irska Tel. št.: + 35319201427 regulatoryaffairs@theratech.com
• spots or swelling
• madeži ali otekanje
Trogarzo will be added to a drip (infusion bag) containing a sodium chloride (saline) solution before use.
Zdravilo Trogarzo se pred uporabo doda kapalni infuziji (infuzijski vrečki), ki vsebuje raztopino natrijevega klorida (fiziološka raztopina).
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.
Študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PAES): Da bi dodatno opredelili učinkovitost ibalizumaba v kombinaciji z drugimi protiretrovirusnimi zdravili za zdravljenje odraslih, okuženih z virusom HIV-1, ki je odporen proti več zdravilom, in za katere zato ni mogoče zgraditi supresivnega protivirusnega režima, mora imetnik dovoljenja za promet z zdravilom izvesti in predložiti rezultate študije, ki temelji na podatkih iz registra zdravila.
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.
Po priporočeni shemi odmerjanja (enkratni polnilni odmerek 2.000 mg, ki mu je sledil vzdrževalni odmerek 800 mg vsaka 2 tedna) so koncentracije ibalizumaba dosegle stanje dinamičnega ravnovesja po prvem vzdrževalnem odmerku 800 mg s srednjo najnižjo koncentracijo nad 30 µg/ml med celotnim intervalom odmerjanja.
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.
Glede na mehanizem delovanja in ciljno usmerjeno porazdelitev ibalizumaba ni pričakovati, da bi ta imel medsebojne farmakokinetične interakcije z drugimi zdravili.
• Once diluted, the ibalizumab solution should be administered immediately.
• Ko je raztopina ibalizumaba razredčena, jo je treba takoj uporabiti.
**Includes pooled terms “rash”, “rash erythematous”, “rash generalized”, “rash macular”, “rash maculopapular”, “rash pruritic” and “rash papular”.
**Vključuje skupne izraze „izpuščaj“, „eritematozni izpuščaj“, „generaliziran izpuščaj“, „makularni izpuščaj“, „makulopapularni izpuščaj“, „pruritični izpuščaj“ in „papularni izpuščaj“.
Trogarzo contains less than 1 mmol sodium (23 mg) in each dose and therefore is essentially sodium-free.
Zdravilo Trogarzo vsebuje manj kot 1 mmol natrija (23 mg) v enem odmerku, kar v bistvu pomeni „brez natrija“.
** 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.
* natančen 95-% interval zaupanja ** p < 0,0001, ki temelji na McNemarjevem testu, ki primerja delež udeležencev, ki so dosegli zmanjšanje virusne obremenitve za ≥ 0,5 log10 ob koncu obdobij nadzorovanja in funkcionalne monoterapije.
Ibalizumab pharmacokinetics have not been evaluated in paediatric patients.
Farmakokinetika ibalizumaba pri pediatričnih bolnikih ni bila ocenjena.
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).
Opaženo je bilo zvišanje povprečnega števila T-celic CD4+ od izhodišča do 25. tedna za 62 celic/mm3 (analiza populacije z namenom zdravljenja (ITT)).
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.
Da bi se izognili prenosu virusa HIV na dojenčka, je priporočljivo, da ženske, okužene z virusom HIV,
As a result, ibalizumab was discontinued.
Zato je bila uporaba ibalizumaba prekinjena.
If no infusionassociated adverse reactions have occurred, the duration of the subsequent infusions (maintenance doses) can be decreased to no less than 15 minutes.
Če se neželeni učinki, povezani z infuzijo, niso pojavili, se lahko trajanje nadaljnjih infuzij (vzdrževalnih odmerkov) skrajša na ne manj kot 15 minut.
Store and transport refrigerated (2°C to 8°C).
Shranjujte in prevažajte v hladilniku (2-8 °C).
Other medicines and Trogarzo Tell your doctor if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
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).
Trogarzo za eno ali več podskupin pediatrične populacije pri zdravljenju okužbe z virusom HIV-1 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
6.6 Special precautions for disposal and other handling This medicinal product should be inspected visually for particulate matter and discoloration prior to administration.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Pred uporabo je treba to zdravilo vizualno pregledati, da ne vsebuje trdih delcev in ni spremenjene barve.
Fifty-five percent of subjects had a ≥ 1 log10 reduction in viral load, and 48% of subjects had a ≥
Pri 55 % preiskovancev se je v 25. tednu virusna obremenitev zmanjšala za ≥ 1 log10, pri 48 %
All 153 subjects enrolled in Phase 2b and 3 clinical trials were tested for the presence of anti-ibalizumab IgG antibodies throughout their participation.
Vseh 153 preiskovancev, vključenih v 2.b in 3. fazo kliničnih preskušanj, je bilo v času njihovega sodelovanja v študiji testiranih na prisotnost protiteles proti IgG.