FrancophonIA/ELRC3.0 huggingface dataset:
English: • Push the plunger rod down slowly until all the liquid has emptied into the vial.
Estonian: • Vajutage aeglaselt kolvivardale, kuni kogu vedelik on viaali süstitud.
English: Tel: 1800 633 363 (toll free)
Estonian: Pfizer Healthcare Ireland Tel: +1 800 633 363 (toll free)
English: Do not inject a double dose to make up for forgotten individual doses.
Estonian: Ärge süstige kahekordset annust, kui ravim jäi eelmisel korral süstimata.
English: • Fold the needle guard out of the way of the needle cover.
Estonian: • Painutage nõelakaitset eemale nõelakattest.
English: • Remove the cap from the vial.
Estonian: • Eemaldage viaalilt kork.
English: • Immediately perform a comprehensive hepatic workup.
Estonian: • Tehke kohe põhjalikud maksauuringud.
English: • May continue therapy with SOMAVERT.
Estonian: • SOMAVERT-ravi võib jätkata.
English: Metabolism and nutrition disorders hypercholesterol aemia, hyperglycaemia, hypoglycaemia, weight increased hypertriglyceridemia
Estonian: Ainevahetus- ja toitumishäired hüperkolesteroleemia, hüperglükeemia, hüpoglükeemia, kehakaalutõus hüpertriglütserideemia
English: • Increased levels of substances that measure the function of the liver.
Estonian: • Maksafunktsiooni näitajate taseme tõus; neid saab määrata vereproovist.
English: • Anger
Estonian: • Viha.
English: - SOMAVERT 20 mg: One vial of powder contains 20 mg pegvisomant.
Estonian: - SOMAVERT 20 mg: Üks viaal pulbriga sisaldab 20 mg pegvisomanti.
English: Remove syringe cap
Estonian: Süstlikorgi eemaldamine klõps
English: Swirl vial
Estonian: Viaali pööramine
English: • Insert the needle to its full depth into the pinched skin.
Estonian: • Sisestage nõel kogu pikkuses nahavolti.
English: You should not breast-feed while taking SOMAVERT unless your doctor has discussed this with you.
Estonian: SOMAVERT'i ravi ajal ei tohi last rinnaga toita ilma arstiga nõu pidamata.
English: - SOMAVERT 25 mg: One vial of powder contains 25 mg pegvisomant.
Estonian: - SOMAVERT 25 mg: Üks viaal pulbriga sisaldab 25 mg pegvisomanti.
English: The 15 mg strength of the medicinal product contains 0.4 mg of sodium per vial of powder.
Estonian: Ravimi 15 mg annus sisaldab 0,4 mg naatriumi pulbriviaali kohta.
English: Check medicine
Estonian: Ravimi kontrollimine
English: • Decreased platelets in the blood, increased or decreased white cells in the blood, tendency to bleed.
Estonian: • Vereliistakute arvu vähenemine, vere valgeliblede arvu suurenemine või vähenemine,
English: - SOMAVERT 30 mg: One vial of powder contains 30 mg pegvisomant.
Estonian: - SOMAVERT 30 mg: Üks viaal pulbriga sisaldab 30 mg pegvisomanti.
English: Dispose
Estonian: KÕLBLIKKUSAEG
English: • Rapid swelling of skin and underlying tissue and inner lining (mucosa) of organs
Estonian: • Naha, nahaaluskohe ja siseelundite limaskesta äge turse (angioödeem).
English: - SOMAVERT 15 mg: One vial of powder contains 15 mg pegvisomant.
Estonian: - SOMAVERT 15 mg: Üks viaal pulbriga sisaldab 15 mg pegvisomanti.
English: Is it OK to shake the vial if the powder is not dissolving?
Estonian: Kui pulber ei lahustu, kas siis tohib viaali loksutada?
English: This leaflet was last revised in <{MM/YYYY}>.
Estonian: Infoleht on viimati uuendatud:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON
Estonian: MINIMAALSED ANDMED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
English: • Dizziness, sleepiness, uncontrolled trembling, decreased sense of touch.
Estonian: • Pearinglus, unisus, tahtmatud värinad, puutetundlikkuse nõrgenemine.
English: - SOMAVERT 10 mg: One vial of powder contains 10 mg pegvisomant.
Estonian: - SOMAVERT 10 mg: Üks viaal pulbriga sisaldab 10 mg pegvisomanti.
English: • Severe breathlessness (laryngospasm)
Estonian: • süstel lahustiga,
English: 1 pre-filled syringe of solvent 1 injection needle
Estonian: 1 viaal pulbriga 1 süstel lahustiga 1 süstlanõel
English: • Facial swelling, dry skin, night sweats, redness of the skin (erythema), raised itchy bumps on the skin (urticaria).
Estonian: • Näopunetus, nahakuivus, öine higistamine, nahapunetus (erüteem), sügelevad kublad nahal
English: • No-never shake the vial.
Estonian: • Ei, viaali ei tohi mingil juhul loksutada.
English: • Keep the syringe upright to avoid leakage.
Estonian: • Hoidke süstlit püstiasendis, sellega väldite lekkimist.
English: SOMAVERT 20 mg powder and solvent for solution for injection One vial contains 20 mg of pegvisomant.
Estonian: SOMAVERT 20 mg süstelahuse pulber ja lahusti Üks viaal sisaldab 20 mg pegvisomanti.
English: Disodium phosphate anhydrous Sodium dihydrogen phosphate monohydrate
Estonian: Veevaba dinaatriumvesinikfosfaat Naatriumdivesinikfosfaatmonohüdraat
English: • Diarrhoea
Estonian: • vatitups,
English: Insert needle
Estonian: Nõela sisestamine
English: SOMAVERT 30 mg powder and solvent for solution for injection One vial contains 30 mg of pegvisomant.
Estonian: SOMAVERT 30 mg süstelahuse pulber ja lahusti Üks viaal sisaldab 30 mg pegvisomanti.
English: After reconstitution, 1 ml of solution contains 20 mg of pegvisomant.
Estonian: Pärast manustamiskõlblikuks muutmist sisaldab 1 ml lahust 20 mg pegvisomanti.
English: Disodium phosphate anhydrous Sodium dihydrogen phosphate monohydrate Water for Injections
Estonian: Veevaba dinaatriumvesinikfosfaat Naatriumdivesinikfosfaatmonohüdraat Süstevesi
English: Reposition needle
Estonian: Reied
English: SOMAVERT 25 mg powder and solvent for solution for injection One vial contains 25 mg of pegvisomant.
Estonian: SOMAVERT 25 mg süstelahuse pulber ja lahusti Üks viaal sisaldab 25 mg pegvisomanti.
English: SOMAVERT 10 mg powder and solvent for solution for injection One vial contains 10 mg of pegvisomant.
Estonian: SOMAVERT 10 mg süstelahuse pulber ja lahusti Üks viaal sisaldab 10 mg pegvisomanti.
English: After reconstitution, 1 ml of solution contains 25 mg of pegvisomant.
Estonian: Pärast lahustamist 1 ml lahustiga, sisaldab 1 ml lahust 25 mg pegvisomanti.
English: SOMAVERT 15 mg powder and solvent for solution for injection One vial contains 15 mg of pegvisomant.
Estonian: SOMAVERT 15 mg süstelahuse pulber ja lahusti Üks viaal sisaldab 15 mg pegvisomanti.
English: Excipient with known effect The 30 mg strength of the medicinal product contains 0.6 mg of sodium per vial of powder.
Estonian: Ravimi 30 mg annus sisaldab 0,6 mg naatriumi pulbriviaali kohta.
English: SOMAVERT 20 mg powder for injection pegvisomant SC
Estonian: SOMAVERT 20 mg süstelahuse pulber pegvisomant
English: • Tilt both the vial and syringe at an angle, as shown.
Estonian: • Hoidke nii viaali kui süstlit nurga all, nagu näidatud.
English: After reconstitution, 1 ml of solution contains 15 mg of pegvisomant.
Estonian: Pärast lahustamist 1 ml lahustiga, sisaldab 1 ml lahust 15 mg pegvisomanti.
English: SOMAVERT 15 mg powder for injection pegvisomant SC
Estonian: SOMAVERT 15 mg süstelahuse pulber pegvisomant
English: SOMAVERT 30 mg powder for solution for injection pegvisomant
Estonian: SOMAVERT 30 mg süstelahuse pulber pegvisomant
English: SOMAVERT 25 mg powder for solution for injection pegvisomant
Estonian: SOMAVERT 25 mg süstelahuse pulber pegvisomant
English: After reconstitution, 1 ml of solution contains 30 mg of pegvisomant.
Estonian: Pärast lahustamist 1 ml lahustiga, sisaldab 1 ml lahust 30 mg pegvisomanti.
English: Make needle safe
Estonian: Nõela turvaline käsitsemine
English: Preclinical safety data
Estonian: Turvanõela kinnitamine
English: After reconstitution, 1 ml of solution contains 10 mg of pegvisomant.
Estonian: Pärast lahustamist 1 ml lahustiga, sisaldab 1 ml lahust 10 mg pegvisomanti.
English: SOMAVERT 10 mg powder for injection pegvisomant SC
Estonian: SOMAVERT 10 mg süstelahuse pulber Pegvisomant
English: Inject medicine
Estonian: Ravimi süstimine
English: • Abnormal sense of taste, migraine.
Estonian: • Maitsetundlikkuse häired, migreen.
English: PHARMACEUTICAL FORM Powder and solvent for solution for injection (powder for injection).
Estonian: Süstelahuse pulber ja lahusti (süstepulber).
English: 1 ml of solvent, 1 ml of the solution contains 20 mg pegvisomant.
Estonian: Pärast lahustamist 1 ml lahustiga, sisaldab 1 ml lahust 20 mg pegvisomanti.
English: Choose injection area
Estonian: Süstelahuse pulber
English: SOMAVERT 25 mg powder for injection pegvisomant SC
Estonian: SOMAVERT 25 mg süstepulber pegvisomant s.c.
English: SOMAVERT 30 mg powder for injection pegvisomant SC
Estonian: SOMAVERT 30 mg süstepulber pegvisomant s.c.
English: SOMAVERT 20 mg powder and solvent for solution for injection pegvisomant
Estonian: SOMAVERT 20 mg süstelahuse pulber ja lahusti pegvisomant
English: Excipient with known effect The 10 mg strength of the medicinal product contains 0.4 mg of sodium per vial of powder.
Estonian: Ravimi 10 mg annus sisaldab 0,4 mg naatriumi pulbriviaali kohta.
English: Respiratory, thoracic and mediastinal disorders dyspnoea laryngospasmb
Estonian: Respiratoorsed, rindkere ja mediastiinumi häired düspnoe larüngospasm
English: SOMAVERT 25 mg powder and solvent for solution for injection pegvisomant
Estonian: SOMAVERT 25 mg süstelahuse pulber ja lahusti pegvisomant
English: • Constipation, feeling sick, being sick, feeling bloated, indigestion, gas.
Estonian: • Kõhukinnisus, iiveldus, oksendamine, kõhupuhitus, seedehäire, gaaside kogunemine.
English: Excipient with known effect: The 20 mg strength of the medicinal product contains 0.4 mg of sodium per vial of powder.
Estonian: Ravimi 20 mg annus sisaldab 0,4 mg naatriumi pulbriviaali kohta.
English: SOMAVERT 30 mg powder and solvent for solution for injection pegvisomant
Estonian: SOMAVERT 30 mg süstelahuse pulber ja lahusti pegvisomant
English: SOMAVERT 10 mg powder and solvent for solution for injection pegvisomant
Estonian: SOMAVERT 10 mg süstelahuse pulber ja lahusti pegvisomant
English: SOMAVERT 15 mg powder and solvent for solution for injection pegvisomant
Estonian: SOMAVERT 15 mg süstelahuse pulber ja lahusti pegvisomant
English: • Sweating, itching, rash, tendency to bruise.
Estonian: • Higistamine, sügelemine, lööve, kalduvus verevalumite tekkeks.
English: Hepatic or renal impairment
Estonian: Maksa- või neerufunktsiooni kahjustus
English: Undesirable effects
Estonian: Vajalikud vahendid
English: Date of first authorisation: 22 November 2018
Estonian: Esmase müügiloa väljastamise kuupäev: 22. november 2018
English: 2132NP Hoofddorp Netherlands
Estonian: 2132 NP Hoofddorp Holland
English: The majority of patients recovered from infection.
Estonian: Enamik patsientidest taastus infektsioonist.
English: Each arm enrolled 186 patients.
Estonian: Kummassegi rühma registreeriti 186 patsienti.
English: • Each vial is for single use only.
Estonian: • Iga viaal on mõeldud ainult ühekordseks kasutamiseks.
English: 100-1 Hagiwara-machi, Takasaki-shi, Gunma, 370-0013, Japan
Estonian: 100-1 Hagiwara-machi, Takasaki-shi Gunma, 370-0013, Jaapan
English: Response in skin and blood was evaluated every 4 weeks.
Estonian: Ravivastust nahale ja verele hinnati iga 4 nädala järel.
English: However, the medicine can cause tiredness in some people, so take particular care when driving and using machines until you are certain that this medicine does not affect you.
Estonian: Kuid see ravim võib põhjustada mõnel inimesel väsimust, seega olge auto juhtimisel ja masinate kasutamisel eriti ettevaatlik, kuni olete kindel, et see ravim teid ei mõjuta.
English: This medicine should not be used in children and adolescents below 18 years of age.
Estonian: See ravim ei ole ette nähtud kasutamiseks lastel ega noorukitel vanuses alla 18 aasta.
English: Treatment must be initiated and supervised by physicians experienced in the treatment of cancer, and should only be administered by healthcare professionals in an environment where resuscitation equipment is available.
Estonian: Ravi peab alustama ja jälgima vähiravis kogenud arst ning seda võivad manustada ainult tervishoiutöötajad keskkonnas, kus on kättesaadavad elustamisvahendid.
English: This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.
Estonian: Infoleht on viimati uuendatud <{KK/AAAA}> <{kuu AAAA}>.
English: Linearity and accumulation
Estonian: Lineaarsus ja akumulatsioon
English: In case of overdose, the patient, including their vital signs, should be closely monitored (for at least 1 hour) and supportive treatment should be administered if required.
Estonian: Üleannustamise korral tuleb patsienti, sealhulgas tema elutähtsaid näitajaid, hoolikalt jälgida (vähemalt 1 tund) ja anda vajaduse korral toetavat ravi.
English: Disease stage IB/II
Estonian: Haiguse IB/II aste
English: Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to the breast-fed child cannot be excluded during this short period.
Estonian: Inimesel erituvad IgG-d teadaolevalt rinnapiima esimestel päevadel pärast sündi ning varsti pärast seda nende kontsentratsioon väheneb madalale tasemele; seega ei saa riski imetatavale lapsele sellel lühikesel perioodi välistada.
English: a: P-value was obtained from Cochran-Mantel-Haenszel test adjusting for disease type, disease stage, and region.
Estonian: a: P-väärtus arvutati Cochran-Mantel-Haenszeli testiga, kohandades seda haiguse tüübi, haiguse astme ja piirkonnaga.
English: As a precautionary measure, it is preferable to avoid the use of mogamulizumab during pregnancy.
Estonian: Ettevaatusena on parem vältida mogamulizumabi kasutamist raseduse ajal.
English: Afterwards POTELIGEO could be used during breast-feeding if clinically needed.
Estonian: Seejärel võib POTELIGEO-t imetamise ajal kasutada, kui see on kliiniliselt vajalik.
English: When the symptoms go away, POTELIGEO can normally continue to be given, but more slowly.
Estonian: Pärast sümptomite kadumist võib POTELIGEO manustamist üldjuhul jätkata, kuid aeglasemalt.
English: • Administer infusion solution over at least 60 minutes through an intravenous line containing a sterile, low protein binding 0.22 micron (or equivalent) in-line filter.
Estonian: • Infusioonilahust tuleb manustada vähemalt 60 minuti jooksul intravenoosse liini kaudu, milles on steriilne, valkudega väheseonduv 0,22-mikroniline (või samaväärne) sisefilter.
English: If this happens, the infusion may need to be stopped and you may require additional treatment.
Estonian: Sel juhul võib olla vajalik infusioon katkestada ja võite vajada lisaravi.
English: The safety and efficacy of POTELIGEO in children and adolescents aged below 18 years has not been established.
Estonian: POTELIGEO ohutus ja efektiivsus lastel ja alla 18-aastastel noorukitel ei ole tõestatud.
English: Treatment with mogamulizumab continued until disease progression or unacceptable toxicity.
Estonian: Ravi mogamulizumabiga jätkati kuni haiguse progresseerumiseni või vastuvõetamatu toksilisuse tekkimiseni.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not be longer than a total of 4 hours at 2°C - 8°C provided that dilution has taken place under controlled and validated aseptic conditions.
Estonian: Kui ravimit ei kasutata kohe, vastutab selle säilitamisaja ja -tingimuste eest kasutaja ning need ei tohi ületada kokku 4 tundi temperatuuril 2°C...8 °C, kui lahjendamine toimus kontrollitud ja aseptilistes tingimustes.
English: POTELIGEO should be administered within 2 days of the scheduled day.
Estonian: POTELIGEO-t tuleb manustada 2 päeva jooksul enne või pärast ettenähtud päeva.
English: If a compartment level response or overall response is not observed after 3 months of treatment, discontinuation of treatment should be considered.
Estonian: Kui pärast 3-kuulist ravi ei ole ravivastust piirkonna tasandil ega üldist ravivastust täheldatud, tuleb kaaluda ravi lõpetamist.
English: Mogamulizumab is produced in Chinese hamster ovary cells by recombinant DNA technology.
Estonian: Mogamulizumabi toodetakse hiina hamstri munasarja rakkudes rekombinantse DNA tehnoloogiaga.
English: What you need to know before you use POTELIGEO Do not use POTELIGEO if you are:
Estonian: Mida on vaja teada enne POTELIGEO kasutamist Ärge kasutage POTELIGEO-t:
English: You must tell your doctor or nurse if you are pregnant, breast-feeding, think you may be pregnant, or are planning to have a baby.
Estonian: Peate teatama oma arstile või meditsiiniõele, kui te olete rase, imetate või arvate end olevat rase või kavatsete rasestuda.
English: - allergic to mogamulizumab or any of the other ingredients of this medicine (listed in section 6).
Estonian: - kui olete mogamulizumabi või selle ravimi mis tahes koostisosade (loetletud lõigus 6) suhtes allergiline.
English: Patients who have risk factors associated with cardiac disease should be monitored and appropriate precautions taken.
Estonian: Südamehaigusega seotud riskiteguritega patsiente tuleb jälgida ja võtta kasutusele sobivaid ettevaatusabinõusid.
English: Reasons for crossover to mogamulizumab were disease progression (109 patients) and treatment intolerance (27 patients).
Estonian: Põhjused mogamulizumabi rühma üleviimiseks olid haiguse progresseerumine (109 patsienti) ja ravi talumatus (27 patsienti).
English: If a dose is missed by more than 2 days, the next dose should be administered as soon as possible, after which the dosing schedule should be resumed with doses given based on the new scheduled days.
Estonian: Kui annusega hilinetakse rohkem kui 2 päeva, tuleb järgmine annus manustada niipea kui võimalik ning seejärel jätkata annustamise ajakavaga, milles manustatakse annused uutel ettenähtud päevadel.
English: Patients should be monitored closely by appropriate laboratory and clinical tests for electrolyte status, hydration and renal function, particularly in the first month of treatment, and managed according to best medical practice.
Estonian: Patsientidel tuleb hoolikalt jälgida sobivate laborianalüüside ja kliiniliste testidega elektrolüütide sisaldust, hüdreeritust ja neerufunktsiooni, eelkõige esimesel ravikuul, ning neid parima ravitava kohaselt ravida.
English: No specific studies have been conducted to evaluate potential effects on fertility.
Estonian: Spetsiaalseid uuringuid potentsiaalsete mõjude hindamiseks fertiilsusele ei ole läbi viidud.
English: See section 2 “POTELIGEO contains sodium”.
Estonian: Vt lõik 2 „POTELIGEO sisaldab naatriumi“.
English: Severe reactions (Grade 3) were experienced by 4% of patients.
Estonian: Raskeid reaktsioone (3. aste) tekkis 4%-l patsientidest.
English: Patients should be monitored for signs and symptoms of infection and treated promptly.
Estonian: Patsiente tuleb jälgida infektsiooni tunnuste ja sümptomite suhtes ja kohe ravida.
English: POTELIGEO will be given to you through a vein (intravenous infusion) over at least 60 minutes.
Estonian: POTELIGEO-t manustatakse teile veeni kaudu (intravenoosse infusioonina) vähemalt 60 minuti jooksul.
English: Mogamulizumab is dosed via intravenous route and therefore is immediately and completely bioavailable.
Estonian: Imendumine Mogamulizumabi annustatakse intravenoosselt ning see on seetõttu kohe ja täielikult biosaadav.
English: Contents of the pack and other information What POTELIGEO contains
Estonian: Pakendi sisu ja muu teave Mida POTELIGEO sisaldab
English: The final concentration of the diluted solution should be between 0.1 mg/mL to 3.0 mg/mL.
Estonian: Lahjendatud lahuse lõplik kontsentratsioon peab olema vahemikus 0,1 mg/ml kuni 3,0 mg/ml.
English: Discard any unused portion left in the vial in accordance with local requirements.
Estonian: Viaali jäänud kasutamata lahus tuleb ära visata vastavalt kohalikele nõuetele.
English: What POTELIGEO is and what it is used for What you need to know before you use POTELIGEO How POTELIGEO is given Possible side effects
Estonian: Mis ravim on POTELIGEO ja milleks seda kasutatakse Mida on vaja teada enne POTELIGEO kasutamist Kuidas POTELIGEO-t manustatakse Võimalikud kõrvaltoimed
English: Infusion-related reactions have been observed in 33% of patients treated with POTELIGEO.
Estonian: Infusiooniga seotud reaktsioone täheldati 33%-l POTELIGEO-ga ravitud patsientidest.
English: The median duration of exposure with mogamulizumab was 5.6 months (range: <1 to 45.3 months).
Estonian: Mogamulizumabravi mediaanne kestus oli 5,6 kuud (vahemik: < 1 kuni 45,3 kuud).
English: Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature (at 25°C) under ambient room light.
Estonian: Ravimi kasutusaegne keemilis-füüsikaline stabiilsus on tõestatud toavalguses 24 tunni jooksul toatemperatuuril (25°C).
English: POTELIGEO does not contain a preservative.
Estonian: POTELIGEO ei sisalda säilitusainet.
English: Do not use this medicine after the expiry date which is stated on the carton and the vial after “EXP”.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud karbil ja viaalil pärast „Kõlblik kuni/EXP“.
English: There were no positive neutralising antibody responses.
Estonian: Neutraliseerivate antikehade suhtes positiivseid tulemusi ei olnud.
English: To start with, the infusions will be given once a week for the first 5 doses, then once every 2 weeks.
Estonian: Infusioone manustatakse esimesed 5 annust üks kord nädalas ja seejärel iga 2 nädala järel.
English: Carcinogenicity or genotoxicity studies have not been conducted with mogamulizumab.
Estonian: Kantserogeensuse või genotoksilisuse uuringuid ei ole mogamulizumabiga läbi viidud.
English: Mogamulizumab targets cancer cells which are then destroyed by the immune system (the body's defence).
Estonian: Mogamulizumab on suunatud vähirakkudele, mille immuunsüsteem (keha kaitsemehhanism) seejärel hävitab.
English: Blood (n)
Estonian: Veri (n)
English: Severe adverse reactions included Grade 4 respiratory failure (1.1%) and Grade 5 reactions were polymyositis and sepsis (0.5% each).
Estonian: Rasked kõrvaltoimed olid muu hulgas 4. astme hingamispuudulikkus (1,1%) ning 5. astme reaktsioonid olid polümüosiit ja sepsis (kumbagi 0,5%).
English: Once opened, the medicinal product should be diluted and infused immediately (see section 6.6).
Estonian: Ravim tuleb pärast avamist kohe lahjendada ja infundeerida (vt lõik 6.6).
English: The safety profile observed in the 90 days following the last dose of mogamulizumab is consistent with the safety profile observed during the study treatment period.
Estonian: 90 päeva jooksul mogamulizumabi viimasest annusest täheldatud ohutusprofiil vastab uuringuravi perioodil täheldatud ohutusprofiilile.
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Estonian: Nagu kõik raviotstarbel kasutatavad valgud, on see valk potentsiaalselt immunogeenne.
English: Infusion interruptions occurred in approximately 6% of patients, most of which (approximately 90%) occurred within the first cycle of treatment with mogamulizumab.
Estonian: Infusiooni katkestusi tekkis ligikaudu 6%-l patsientidest, enamasti (ligikaudu 90%) mogamulizumabravi esimese tsükli ajal.
English: At study baseline, 38% had stage IB-II disease, 10% stage III, 52% stage IV.
Estonian: Uuringu algul oli 38%-l IB-II astme haigus, 10%-l III astme haigus, 52%-l IV aste.
English: If reaction recurs, discontinuing the infusion should be considered (see section 4.4).
Estonian: Reaktsiooni kordumisel tuleb kaaluda infusiooni lõpetamist (vt lõik 4.4).
English: This study included patients regardless of their baseline level of CCR4 expression in skin biopsy.
Estonian: Sellesse uuringusse kaasati patsiente olenemata nende CCR4 ekspressiooni ravieelsest tasemest naha biopsias.
English: Mogamulizumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Estonian: Mogamulizumab laguneb eeldatavalt väikesteks peptiidideks ja aminohapeteks kataboolsete teede kaudu samal viisil kui endogeenne IgG.
English: Due to the mechanism of action of the medicine, it may harm your baby if it is administered when you are pregnant or breast- feeding.
Estonian: Ravimi toimemehhanismi tõttu võib see raseduse või imetamise ajal manustamise korral teie last kahjustada.