FrancophonIA/ELRC3.0 huggingface dataset:
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.
Estonian: Üldiselt tekkisid lööbed varakult (st 1…3 nädalat pärast esimest ibalizumabi annust), olid kerged kuni mõõdukad ja kadusid 1…3 nädalat jooksul ibalizumabi manustamise jätkumisel.
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.
Estonian: Kreatiniinisisalduse 3. astme suurenemine esines sageli osalejatel, kellel oli kaasuv neeruhaigus, esinesid neeruhaiguse riskitegurid ja/või kes samaaegselt kasutasid teadaolevalt nefrotoksilisi ravimeid.
English: A pre- and post-natal developmental study was performed in cynomolgus monkeys.
Estonian: Sünnieelse ja -järgse arengu uuring tehti makaakidega.
English: Cardiac disorders ventricular extrasystoles, electrocardiogram abnormal
Estonian: Südame häired vatsakeste ekstrasüstolid, ebanormaalne elektrokardiogramm
English: There are no data on the effects of ibalizumab on human fertility.
Estonian: Ibalizumabi mõju kohta inimese fertiilsusele andmed puuduvad.
English: • Once diluted, the ibalizumab solution should be administered immediately.
Estonian: • Lahjendatud ibalizumabi lahus tuleb manustada kohe.
English: If the patient does not experience an infusion-associated adverse reaction, the post-infusion observation time can be reduced to 15 minutes thereafter.
Estonian: Kui patsiendil ei teki infusiooniga seotud kõrvaltoimeid, võib infusioonijärgset jälgimist lühendada 15 minutini.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Estonian: Tervishoiutöötajatel palutakse kõigist võimalikest kõrvaltoimetest teatada riikliku teavitamissüsteemi (vt V lisa).
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.
Estonian: Alates 16. nädalast oli platseebo haru viroloogilise ravi ebaõnnestumisega patsientidel võimalus saada avatult 15 mg/kg ibalizumabi iga 2 nädala järel ja/või üle minna uuele optimeeritud taustravile.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Estonian: TEKSTI LÄBIVAATAMISE KUUPÄEV {PP kuu AAAA} Täpne teave selle ravimpreparaadi kohta on saadaval Euroopa Ravimiameti kodulehel http://www.ema.europa.eu.
English: It is unknown if Trogarzo can pass into breast milk.
Estonian: Ei ole teada, kas Trogarzo eritub rinnapiima.
English: Keep the vial in the outer carton in order to protect from light.
Estonian: Hoida viaal väliskarbis, valguse eest kaitstult.
English: Ibalizumab was administered to pregnant females at a 110mg/kg weekly dose from gestation Day 20-22 until parturition (approximately 22 doses/animal).
Estonian: Ibalizumabi manustati tiinetele emasloomadele annuses 110 mg/kg nädalas 20. kuni 22. tiinuspäevast kuni poegimiseni (ligikaudu 22 annust looma kohta).
English: Only one subject was found to have anti-ibalizumab antibodies.
Estonian: Ainult ühel uuringus osalejal leiti ibalizumabivastased antikehad.
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).
Estonian: Kõik subjektid said optimeeritud taustravi ja kasutasid lisaks ühte järgmistest raviskeemidest: vahelduvad intravenoossed infusioonid 15 mg/kg ibalizumabi ja platseeboga esimese 9 annuse korral iga nädal (kuni 8. nädala visiidini), seejärel intravenoossed infusioonid 15 mg/kg ibalizumabiga iga 2 nädala järel (A haru); 10 mg/kg ibalizumabi intravenoossed infusioonid esimese 9 annuse korral iga nädal (kuni 8. nädala visiidini), seejärel 10 mg/kg ibalizumabi intravenoossed infusioonid iga 2 nädala järel (B haru); või iganädalased intravennossed platseebo infusioonid esimese 9 annuse korral (kuni 8. nädala visiidini), seejärel intravenoossed platseebo infusioonid iga 2 nädala järel (platseebo haru).
English: The safety and efficacy of ibalizumab in geriatric patients (≥ 65 years of age) have not been established.
Estonian: Ibalizumabi ohutus ja efektiivsus ei ole tõestatud eakatel (≥ 65-aastastel) patsientidel.
English: Look out for side effects
Estonian: Pange tähele kõrvaltoimeid
English: It will be used together with other HIV medicines called ‘antiretrovirals'.
Estonian: Seda kasutatakse koos teiste HIV-ravimitega, mida nimetatakse retroviirusvastasteks ravimiteks.
English: Decreased susceptibility to ibalizumab was a finding in the majority of patients who experienced virologic failure up to week 24 in the pivotal study.
Estonian: Vähenenud tundlikkust ibalizumabi suhtes leiti põhiuuringu 24. nädalani enamikul patsientidel, kellel viroloogiline ravi ebaõnnestus.
English: Marketing Authorisation Holder and manufacturer Theratechnologies International Limited 10 Earlsfort Terrace,
Estonian: Theratechnologies International Limited 10 Earlsfort Terrass
English: Sodium chloride Polysorbate 80
Estonian: Sahharoos Naatriumkloriid Polüsorbaat 80
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.
Estonian: Kui lahjendatud ibasumabi lahust on säilitatud külmas, tuleblahusel lasta enne manustamist soojeneda toatemperatuuril (20 °C…25 °C) vähemalt 30 minutit, kuid mitte üle 4 tunni.
English: - One vial contains 200 mg of ibalizumab in 1.33 mL of solution.
Estonian: - Üks viaal sisaldab 200 mg ibalizumabi 1,33 ml lahuses.
English: Dublin 2, D02 T380, Ireland Tel: + 35319201427 regulatoryaffairs@theratech.com
Estonian: 10 Earlsfort Terrass Dublin 2, D02 T380, Iirimaa Tel: + 35319201427 regulatoryaffairs@theratech.com
English: The median time to maximum serum concentration (Tmax) of 2,000 mg and 800 mg is 1 hr and 10 min, respectively.
Estonian: Seerumi maksimaalse kontsentratsiooni (Tmax) saavutamiseks 2000 mg ja 800 mg korral kuluva aja mediaan on vastavalt 1 tund ja 10 minutit.
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.
Estonian: Kui ravimit ei kasutata kohe, võib seda säilitada kuni 4 tundi temperatuuril alla 25 C või kuni 24 tundi külmikus (2 °C…8 °C).
English: Loading dose of 2,000 mg
Estonian: 2000 mg küllastusannus
English: It is unknown whether ibalizumab/metabolites are excreted in human milk.
Estonian: Ei ole teada, kas ibalizumab/metaboliidid erituvad inimese rinnapiima.
English: Keep this medicine out of the sight and reach of children.
Estonian: Hoidke seda ravimit laste eest varjatud ja neile kättesaamatus kohas.
English: If you have any further questions on the use of this medicine, ask your doctor or nurse.
Estonian: Kui teil on täiendavaid küsimusi selle ravimi kasutamise kohta, pidage nõu oma arsti või meditsiiniõega.
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.
Estonian: Lahjendamata ibalizumabi sisaldavad viaalid ja lahjendatud ibalizumabi sisaldavad infusioonikotid tuleb hävitada, kui lahus on hägune, värvimuutus on märgatav või leidub nähtavaid võõrosakesi.
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.
Estonian: *täpne 95% usaldusvahemik ** p < 0,0001 McNemari testi alusel, mis võrdleb nende osalejate osakaalu, kes saavutasid viiruskoormuse vähenemise ≥ 0,5 log10 võrra kontrollperioodi ja funktsionaalse monoteraapia perioodi lõpuks.
English: Ibalizumab pharmacokinetics in geriatric patients (≥ 65 years of age) is limited (n = 5).
Estonian: Eakatel patsientidel (≥ 65-aastased) on ibalizumabi farmakokineetika piiratud (n = 5).
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.
Estonian: Ibalizumabi toimemehhanismi ja sihtmärgi vahendatud ravimi jaotuvuse põhjal ei eeldata, et ibalizumabil on farmakokineetilisi koostoimeid muude ravimitega.
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.
Estonian: Kui ei esine infusiooniga seotud kõrvaltoimeid, võib järgmiste infusioonide (säilitusannused) kestust lühendada kuni 15 minutini.
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.
Estonian: 6.6 Erihoiatused ravimpreparaadi hävitamiseks ja käsitlemiseks Enne manustamist tuleb seda ravimipreparaati visuaalselt kontrollida tahkete osakeste puudumise ja värvusemuutuse suhtes.
English: It belongs to a group of medicines called ‘antiretrovirals'.
Estonian: See kuulub ravimite rühma, mida nimetatakse retroviirusvastasteks ravimiteks.
English: Out of the 153 subjects in Phase 2b and 3 clinical studies, one subject experienced a severe rash (non-serious).
Estonian: 2b faasi ja 3. faasi kliinilistesse uuringutesse kaasatud 153 osalejast tekkis tugev (mitte raske) lööve ühel osalejal.
English: If you are breast-feeding, or thinking about breast-feeding:
Estonian: Kui imetate või plaanite imetamist:
English: Both subjects were discontinued from ibalizumab treatment.
Estonian: Mõlema osaleja ravi ibalizumabiga peatati.
English: You can still pass on HIV when taking this medicine, if you have detectable levels of HIV in your body.
Estonian: Kui kasutate seda ravimit, võib HIV-d siiski üle kanduda, kui teie organismis on HIV tuvastatav sisaldus.
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.
Estonian: Pärast soovitatud annustamisskeemi (ühekordne 2000 mg küllastusannus ja edaspidi 800 mg säilitusannus iga 2 nädala järel) saavutasid ibalizumabi kontsentratsioonid pärast esimese 800 mg säilitusannuse manustamist püsitasakaalu, kusjuures keskmine väikseim kontsentratsioon kogu annustamisvahemikus oli üle 30 µg/ml.
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).
Estonian: 25. nädalaks täheldati CD4+ T-rakkude keskmise arvu 62 rakku/mm3 suurenemist (ravikavatsuse (ITT) analüüs).
English: What Trogarzo is
Estonian: Mis on Trogarzo
English: Fifty-five percent of subjects had a ≥ 1 log10 reduction in viral load, and 48% of subjects had a ≥
Estonian: 55%-l osalejatest vähenes viiruskoormus 25. nädalaks ≥ 1 log10 võrra ja 48%-l ≥ 2 log10 võrra.
English: Tell your doctor or nurse if you notice any of the side effects listed above.
Estonian: Teatage arstile või meditsiiniõele, kui märkate mõnda eelloetletud kõrvaltoimet.
English: • spots or swelling
Estonian: • laigud või tursed
English: What Trogarzo contains - The active substance is ibalizumab.
Estonian: Mida Trogarzo sisaldab - Toimeaine on ibalizumab.
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.
Estonian: Ibalizumabi soovitatav annus on ühekordne 2000 mg küllastusannus, millele järgneb 800 mg säilitusannus iga 2 nädala järel.
English: Each vial contains 200 mg of ibalizumab (in 1.33 mL of solution).
Estonian: Üks viaal sisaldab 200 mg ibalizumabi (1,33 ml lahuses).
English: **Includes pooled terms “rash”, “rash erythematous”, “rash generalized”, “rash macular”, “rash maculopapular”, “rash pruritic” and “rash papular”.
Estonian: **Sisaldab kombineeritud mõisteid „lööve“, „erütematoosne lööve“, „generaliseerunud lööve“, „makulaarne lööve“, „makulopapuloose lööve“, „pruriitiline lööve“ ja „papuloosne lööve“.
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Estonian: Lahjendatud ravimpreparaadi säilitamise tingimused vt lõik 6.3.
English: After the infusion is complete, flush with 30 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
Estonian: Pärast infusiooni loputada 30 ml naatriumkloriidi 9 mg/ml (0,9%) süstelahusega.
English: Ibalizumab is administered intravenously (IV), after diluting the appropriate number of vials in 250 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
Estonian: Ibalizumabi manustatakse intravenoosselt pärast vajaliku arvu viaalide sisu lahjendamist 250 ml naatriumkloriidi 9 mg/ml (0,9 %) süstelahusega.
English: How to store Trogarzo 6.
Estonian: Kuidas Trogarzot säilitada 6.
English: Human immunoglobulin (IgG) is known to cross the placental barrier.
Estonian: Teadaolevalt läbib inimese immunoglobuliin (IgG) platsentaarbarjääri.
English: Nervous system disorders dizziness, headache, paraesthesia
Estonian: Närvisüsteemi häired peapööritus, peavalu, paresteesia
English: Trogarzo is used in combination with other medicines called ‘antiretrovirals'.
Estonian: Trogazrot kasutatakse kombinatsioonis teiste ravimitega, mida nimetatakse retroviirusravimiteks.
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.
Estonian: Annust manustati sellisena vähemalt 10 korda rohkem hinnangulisest vabast kliinilisest AUCst tavatingimustes ja Cmax-ist 800 mg kahe nädala järel manustatud (Q2W) annuse puhul.
English: Do not give this medicine to children and adolescents below 18 years of age.
Estonian: Seda ravimit ei anta lastele ega alla 18-aastastele noorukitele, sest selles vanuserühmas ei ole Trogarzot uuritud.
English: Week 25
Estonian: 31. oktoober 2025
English: Trogarzo will be added to a drip (infusion bag) containing a sodium chloride (saline) solution before use.
Estonian: Enne manustamist lisatakse Trogarzo tilgutisse (infusioonikotti), mis sisaldab naatriumkloriidi lahust (füsioloogilist keedusoolalahust).
English: Beginning at Day 21, an 800 mg maintenance dose of ibalizumab was administered every two weeks through Week 25.
Estonian: Alates 21. päevast manustati iga 2 nädala järel 25. nädalani ibalizumabi 800 mg säilitusannus.
English: Dizziness, nausea, fatigue and headache have been reported during treatment with ibalizumab (see section 4.8).
Estonian: Ravi ajal ibalizumabiga on teatatud peapööritusest, iiveldusest, väsimusest ja peavalust (vt lõik 4.8).
English: How Trogarzo works
Estonian: Kuidas Trogarzo toimib
English: Trogarzo contains less than 1 mmol sodium (23 mg) in each dose and therefore is essentially sodium-free.
Estonian: Trogarzo naatriumisisaldus on väike Iga Trogarzo annus sisaldab alla 1 mmol (23 mg) naatriumi ja on seega põhimõtteliselt naatriumivaba.
English: outcomes are shown in Table 3.
Estonian: 25. nädalaks saadud tulemused on tabelis 3.
English: Post-authorisation efficacy study (PAES):
Estonian: Müügiloa saamise järgne efektiivsusuuring:
English: Other intravenous diluents must not be used to prepare the ibalizumab solution for infusion.
Estonian: Ibalizumabi infusioonilahuse valmistamiseks ei tohi kasutada muid intravenoosseid lahuseid.
English: • Remove the flip-off cap from the vial and wipe with an alcohol swab.
Estonian: • Eemaldage viaalilt kate ja pühkige korgi pealispinda alkoholitampooniga.
English: How to receive Trogarzo 4.
Estonian: Kuidas Trogarzot kasutada 4.
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).
Estonian: 16. nädalaks, st enne platseebo haru patsientide üleminekut ibalizumabi annusele 15 mg/kg iga 2 nädala järel ja/või kõigi patsientide optimeeritud taustravi muutmist, vähenes keskmine viiruskoormus A harus 1,07 log10 koopia/ml, B harus 1,33 log10 koopia/ml ja platseebo harus 0,26 log10 koopia/ml võrra (p=0,002 vs A haru, p<0,001 vs B haru).
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).
Estonian: 2. nädalalaks vähenes keskmine viiruskoormus A harus 0,87 log10 koopia/ml, B harus 1,15 log10 koopia/ml ja platseebo harus 0,38 log10 koopia/ml võrra (p=0,003 vs A haru A, p<0,001 vs B haru).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 200 mg of ibalizumab
Estonian: TOIMEAINE(TE) SISALDUS Üks viaal sisaldab 200 mg ibalizumabi
English: How you will be given Trogarzo The drip (infusion) will be given into a vein over 15 to 30 minutes.
Estonian: Seda manustatakse tilguti abil (infusioonina) veeni 15…30 minuti jooksul.
English: IRIS was reported in 2 subjects out of 153 treated with ibalizumab in Phase 2b and 3 clinical studies (see section 4.8).
Estonian: 2b ja 3. faasi kliinilistes uuringutes osalenud 153 ibalizumabiga ravitust registreeriti IRIS 2 osalejal (vt lõik 4.8).
English: A tabulated list of adverse reactions is presented in Table 1.
Estonian: Kõrvaltoimeteloetelu on esitatud tabelis 1.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of in vitro and in vivo safety assessments.
Estonian: Tavaliste in vitro ja in vivo ohutushinnangu uuringute põhjal saadud mittekliinilised andmed ei näita erilist ohtu inimestele.
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.
Estonian: Ibalizumab sisaldab alla 1 mmol (23 mg) naatriumi iga 2000 mg küllastusannuse või 800 mg säilitusannuse kohta ja on seega põhimõtteliselt naatriumivaba.
English: 2 mL vial (Type I borosilicate glass) sealed with a stopper (butyl rubber) and an aluminum crimp cap.
Estonian: Punnkorgi (butüülkummi) ja alumiiniumümbrisega suletud 2 ml viaal (I tüüpi boorsilikaatklaas).
English: No action was taken with ibalizumab in response to these events.
Estonian: Nende juhtudel ei võetud mingeid meetmeid seoses ibalizumabiga.
English: Trogarzo contains the active substance ibalizumab.
Estonian: Trogarzo sisaldab toimeainena ibalizumabi.
English: 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.
Estonian: Trogarzo on värvusetu kuni kergelt kollakas, läbipaistev kuni kergelt opalestsentne nähtavate osakesteta infusioonilahuse kontsentraat (steriilne kontsentraat).
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use.
Estonian: MANUSTAMISVIIS JA -TEE(D) Enne ravimi kasutamist lugege pakendi infolehte.
English: For instructions on dilution of the medicinal product before administration, see section 6.6.
Estonian: Ravimpreparaadi manustamiseelse lahjendamise juhiseid vt lõik 6.6.
English: What Trogarzo is used for
Estonian: Milleks Trogarzot kasutatakse
English: There are no data from the use of ibalizumab in pregnant women.
Estonian: Ibalizumabi kasutamise kohta rasedatel andmed puuduvad.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Estonian: BIOLOOGILISE TOIMEAINE TOOTJA JA RAVIMIPARTII KASUTAMISEKS VABASTAMISE EEST VASTUTAV TOOTJA
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.
Estonian: Ibalizumabiga ravimise ajal tekkis sellel osalejal eri aegadel 8 lööbelist reaktsiooni, sealhulgas 1 korral makulaarne lööve, 1 korral generaliseerunud lööve ja 6 korral makulopapuloosne lööve.
English: Subjects on a failing ART regimen continued to receive their failing regimen in addition to the loading dose of ibalizumab.
Estonian: Ebaefektiivse retroviirusvastase raviskeemiga osalejad jätkasid ebaefektiivse ravi saamist lisaks ibalizumabi küllastusannusele.
English: Common (may affect up to 1 in 10 people): skin rash
Estonian: Sage (võib esineda kuni 1 inimesel 10-st):
English: See Table 4 below for the appropriate number of vials required to prepare both the loading dose of 2,000 mg and the maintenance doses of 800 mg.
Estonian: Allolev Tabel 4 näitab vajalikku viaalide arvu 2000 mg küllastusannuse ja 800 mg säilitusannuse valmistamiseks.
English: No relevant remaining effect of ibalizumab is expected in cases of resistance development.
Estonian: Resistentsuse tekkimisel ibalizumabil olulisi jääktoimeid ei eeldata.
English: Ibalizumab should be administered as an intravenous infusion.
Estonian: Ibalizumabi manustatakse intravenosse infusioonina.
English: No. of subjects achieving <200 HIV-1 RNA copies/mL (n/N)
Estonian: Osalejate arv, kes saavutasid < 200 koopia/ml (n/N) HIV-1 RNA
English: Ibalizumab should not be administered as an intravenous push or bolus.
Estonian: Ibalizumabi ei tohi manustada veenisisese löökannuse ega boolusena.
English: Gastrointestinal disorders diarrhoea, nausea, vomiting
Estonian: Seedetrakti häired kõhulahtisus, iiveldus, oksendamine
English: Ibalizumab concentrate for solution for infusion should be prepared by a healthcare professional using aseptic technique as follows:
Estonian: Ibalizumabi kontsentraadist peab infusioonilahuse valmistama tervishoiutöötaja, järgides aseptika nõudeid.
English: Pack of 2 vials.
Estonian: Pakendis on 2 viaali.
English: Theratechnologies International Limited 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland Tel: + 35319201427 regulatoryaffairs@theratech.com
Estonian: MÜÜGILOA HOIDJA Theratechnologies International Limited 10 Earlsfort Terrass, Dublin 2, D02 T380, Iirimaa Tel: + 35319201427 regulatoryaffairs@theratech.com MÜÜGILOA NUMBER (NUMBRID) EU/1/19/1359/001 ESMASE MÜÜGILOA VÄLJASTAMISE / MÜÜGILOA UUENDAMISE KUUPÄEV Esmase müügiloa väljastamise kuupäev: {PP kuu AAAA} 10.
English: No. of subjects achieving <50 HIV-1 RNA copies/mL (n/N)
Estonian: Osalejate arv, kes saavutasid < 50 koopia/ml (n/N) HIV-1 RNA
English: There is no known antidote to ibalizumab overdose.
Estonian: Ibalizumabi üleannustamise vastu puudub teadaolev antidoot.
English: Laboratory abnormalities
Estonian: Laboratoorsete näitajate normist kõrvalekalded
English: Hydrochloric acid (for pH-adjustment) Water for injections
Estonian: Vesinikkloriidhape (pH reguleerimiseks) Süstevesi
English: This medicinal product should be inspected visually for particulate matter and discoloration prior to administration.
Estonian: Enne manustamist tuleb seda ravimipreparaati visuaalselt kontrollida tahkete osakeste puudumise ja värvusemuutuse suhtes.
English: Colourless to slightly yellow, clear to slightly opalescent aqueous solution.
Estonian: Värvusetu kuni kergelt kollaka värvusega kergelt opalestsentne vesilahus.
English: Recommended ibalizumab dose and number of vials per administration Ibalizumab dose
Estonian: Ibalizumabi soovituslik annus ja viaalide arv manustamiskorra kohta Ibalizumabi annus
English: Ibalizumab vials (total volume to be withdrawn)
Estonian: Ibalizumabi viaalid (väljatõmmatav kogus)
English: If you miss a dose of Trogarzo
Estonian: Kui jätate Trogarzo annuse vahele