FrancophonIA/ELRC3.0 huggingface dataset:
English: Very common diarrhoea, nausea, constipation, vomiting, abdominal pain, upper abdominal pain
Estonian: Seedetrakti häired Väga sage kõhulahtisus, iiveldus, kõhukinnisus, oksendamine, kõhuvalu, ülakõhuvalu Naha ja nahaaluskoe kahjustused
English: Based on the mechanism of action and nonclinical studies, polatuzumab vedotin can be harmful to the foetus when administered to a pregnant woman.
Estonian: Toimemehhanismi ja mittekliiniliste uuringute põhjal võib polatuzumabvedotiin rasedale manustatuna põhjustada lootekahjustust.
English: • trouble speaking
Estonian: • kõnehäired,
English: Thrombocytopenia events led to discontinuation of treatment in 11.1% of patients in the Polivy plus BR arm and 5.1% of patients in the BR arm. No patients discontinued treatment due to anaemia in either the Polivy plus BR arm or BR arm.
Estonian: Trombotsütopeenia tõttu lõpetas ravi 11,1% patsientidest Polivy pluss BR-i rühmas ja 5,1% patsientidest BR-i rühmas.
English: Pre-existing liver disease, elevated baseline liver enzymes, and concomitant medicinal products may increase the risk.
Estonian: Risk võib olla suurem, kui patsiendil on olemasolev maksahaigus või ravieelselt suurenenud maksaensüümide aktiivsus, samuti võivad riski suurendada samaaegselt kasutatavad ravimid.
English: Polivy is a cancer medicine that contains the active substance polatuzumab vedotin.
Estonian: Polivy on vähiravim, mis sisaldab toimeainet polatuzumabvedotiini.
English: • diarrhoea or constipation
Estonian: • kõhulahtisus või kõhukinnisus,
English: Skin and subcutaneous tissue disorders
Estonian: Lihaste, luustiku ja sidekoe kahjustused Sage liigesevalu
English: • a burning sensation
Estonian: • põletustunne,
English: Polivy is given under the supervision of a doctor experienced in giving such treatments.
Estonian: Polivy'd manustatakse vähiravimite kasutamiskogemusega arsti järelevalve all.
English: • have a fever
Estonian: • palavik ja külmavärinad,
English: METHOD OF ADMINISTRATION For IV use after reconstitution and dilution
Estonian: pärast manustamiskõlblikuks muutmist ja lahjendamist
English: How Polivy is given
Estonian: Kuidas Polivy'd manustatakse
English: • inflammation of the lungs
Estonian: • kõhuvalu,
English: Embryo-foetal toxicity
Estonian: Embrüo-/lootetoksilisus
English: • memory loss
Estonian: • mälukaotus,
English: Keep the vial in the outer carton in order to protect from light
Estonian: Mitte lasta külmuda Hoida viaal karbis valguse eest kaitstult
English: Inspect the reconstituted solution for discoloration and particulate matter.
Estonian: Kontrollige, et manustamiskõlblikuks muudetud lahuses pole ilmnenud värvuse muutuseid ega võõrosakesi.
English: After reconstitution each mL contains 20 mg of polatuzumab vedotin.
Estonian: Pärast manustamiskõlblikuks muutmist sisaldab 1 ml 20 mg polatuzumabvedotiini.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours refrigerated (2 °C − 8 °C), unless dilution has taken place in controlled and validated aseptic conditions.
Estonian: Ravimit võib säilitada kuni 24 tundi külmkapis (2 °C...8 °C), välja arvatud juhul, kui lahjendamine on toimunud kontrollitud ja valideeritud aseptilistes tingimustes.
English: White to greyish-white lyophilized cake.
Estonian: Valge kuni hallikasvalge lüofiliseeritud paakunud pulber.
English: Polivy and any concomitant chemotherapy should be discontinued in patients who develop serious infections.
Estonian: Raskete infektsioonide tekkimisel tuleb ravi Polivy'ga ja igasugune samaaegne kemoteraapia lõpetada.
English: • tingling
Estonian: • pearinglus,
English: • chest pain
Estonian: • rindkere valu,
English: NAME OF THE MEDICINAL PRODUCT Polivy 140 mg powder for concentrate for solution for infusion polatuzumab vedotin
Estonian: RAVIMPREPARAADI NIMETUS Polivy 140 mg infusioonilahuse kontsentraadi pulber polatuzumabvedotiin
English: No studies have been conducted to investigate the pharmacokinetics of polatuzumab vedotin in the paediatric population (<18 years old).
Estonian: Polatuzumabvedotiini farmakokineetika uurimiseks lastel (vanuses alla 18 aasta) ei ole uuringuid läbi viidud.
English: • itchiness
Estonian: • surisemine,
English: Polivy contains sodium
Estonian: Polivy sisaldab naatriumi
English: Polivy 140 mg powder for concentrate for solution for infusion polatuzumab vedotin
Estonian: Polivy 140 mg infusioonilahuse kontsentraadi pulber polatuzumabvedotiin
English: This includes any possible side effects not listed in this leaflet you can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Estonian: Kõrvaltoimetest võite ka ise teatada riikliku teavitussüsteemi (vt V lisa) kaudu.
English: Signs and symptoms of infections vary between individuals, tell your doctor or nurse straight away if you develop symptoms of an infection such as:
Estonian: Teavitage kohe oma arsti või meditsiiniõde, kui teil tekivad sellised infektsiooninähud, nagu:
English: General disorders and administration site conditions Very common fatigue, pyrexia, asthenia, chills Investigations
Estonian: Üldised häired ja manustamiskoha reaktsioonid Väga sage väsimus, palavik, asteenia, külmavärinad
English: Rituximab was administered at 375 mg/m2 on Day 1 of Cycles 1-6.
Estonian: Rituksimabi manustati annuses 375 mg/m2
English: No dedicated fertility studies in animals have been performed with polatuzumab vedotin.
Estonian: Polatuzumabvedotiiniga ei ole loomadel spetsiaalseid fertiilsusuuringuid läbi viidud.
English: Day 1 of any cycle
Estonian: 1. päeval
English: Women of childbearing potential should be advised to use effective contraception during treatment with polatuzumab vedotin and for at least 9 months after the last dose.
Estonian: Rasestumisvõimelised naised peavad ravi ajal polatuzumabvedotiiniga ja vähemalt 9 kuud pärast viimast annust kasutama efektiivseid rasestumisvastaseid meetodeid.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 140 mg of polatuzumab vedotin.
Estonian: Üks viaal sisaldab 140 mg polatuzumabvedotiini.
English: Q3 2020
Estonian: III kvartal
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Polivy 140 mg powder for concentrate polatuzumab vedotin
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE Polivy 140 mg kontsentraadi pulber polatuzumabvedotiin
English: Very common pruritis
Estonian: Väga sage sügelus
English: Posology
Estonian: Kuupäev
English: • fevers and chills
Estonian: • lööve/nõgestõbi,
English: The pharmacokinetics (PK) of rituximab and bendamustine are not affected by co-administration with polatuzumab vedotin.
Estonian: Polatuzumabvedotiini samaaegne manustamine ei mõjuta rituksimabi ega bendamustiini farmakokineetikat (PK).
English: • The active substance is polatuzumab vedotin.
Estonian: • naha ja silmavalgete kollasus (ikterus).
English: Gastrointestinal toxicity
Estonian: Sage pneumoniit
English: This was a reduction of 55%.
Estonian: See on 55% vähenemine.
English: If possible, the first dose should be given before this season starts.
Estonian: Esimene annus tuleb võimaluse korral manustada enne nimetatud hooaja algust.
English: The full EPAR for Synagis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Synagise kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: In children born with heart disease, there was a reduction of 45%.
Estonian: Kaasasündinud südamehaigusega lastel oli vähenemine 45%.
English: It is used in the following groups of children, who are at high risk for this disease:
Estonian: Ravimit kasutatakse järgmiste lasterühmade raviks, kellel on selle haiguse tekke suur risk:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Synagis on 13 August 1999.
Estonian: Euroopa Komisjon andis Synagise müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 13. augustil
English: Synagis palivizumab
Estonian: Synagis palivisumaab
English: • children who are less than six months old and were born five or more weeks prematurely (at 35
Estonian: • alla 6-kuused lapsed, kes on sündinud vähemalt 5 nädalat enneaegselt (35. rasedusnädalal või varem);
English: Patients generally receive a total of five monthly injections into the thigh muscle.
Estonian: Patsiendid saavad üldjuhul kokku viis igakuist süsti reielihasesse.
English: The most common side effects with Synagis (seen in between 1 and 10 patients in 100) are fever and rash.
Estonian: Synagise kõige sagedam kõrvalnäht (esinenud 1-10 patsiendil 100st) on palavik ja lööve.
English: The CHMP decided that Synagis's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Synagise kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: Other information about Synagis
Estonian: Muu teave Synagise kohta
English: • children who are less than two years of age and have had treatment for bronchopulmonary dysplasia (abnormal lung tissue, usually seen in babies born prematurely) within the last six months;
Estonian: • alla 2-aastased lapsed, kes on viimase 6 kuu jooksul vajanud bronhopulmonaalse düsplaasia (ebanormaalne kopsukude, esineb tavaliselt enneaegsetel lastel) ravi;
English: • children who are less than two years of age and were born with a serious heart disease.
Estonian: • alla 2-aastased lapsed, kellel on raske kaasasündinud südamehaigus.
English: When palivizumab is attached to this protein, the virus becomes unable to enter the body's cells, especially those in the lungs.
Estonian: Kui palivisumaab on valguga seondunud, ei saa viirus tungida organismi rakkudesse, eelkõige kopsurakkudesse.
English: For more information about treatment with Synagis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Synagisega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Synagis is given once a month when there is a risk of RSV infection in the community: in the northern hemisphere, this is from November to April.
Estonian: Synagist manustatakse üks kord kuus ajal, mil kasutamiskohas on respiratoor-süntsütiaalviiruse nakkuse oht - põhjapoolkeral novembrist aprillini.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Synagis.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Synagis must not be used in people who are hypersensitive (allergic) to palivizumab, any of the other ingredients or other ‘humanised' monoclonal antibodies.
Estonian: Synagist ei tohi kasutada patsiendid, kes on palivisumaabi, selle ravimi mis tahes muu koostisaine või muude humaniseeritud monoklonaalsete antikehade suhtes ülitundlikud (allergilised).
English: This is a summary of the European public assessment report (EPAR) for Synagis.
Estonian: See on ravimi Synagis Euroopa avaliku hindamisaruande kokkuvõte.
English: For the full list of all side effects reported with Synagis, see the package leaflet.
Estonian: Synagise kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: It contains the active substance palivizumab.
Estonian: Ravim sisaldab toimeainena palivisumaabi.
English: Another study was also carried out comparing Synagis with placebo in 1,287 children who were born with heart disease.
Estonian: Teises uuringus võrreldi Synagist platseeboga 1287 kaasasündinud südamehaigusega lapsel.
English: What is the risk associated with Synagis?
Estonian: Mis riskid Synagisega kaasnevad?
English: This helps to prevent RSV infection.
Estonian: See aitab ennetada respiratoorse süntsütiaalviiruse nakkust.
English: Why has Synagis been approved?
Estonian: Miks Synagis heaks kiideti?
English: Synagis is used to prevent serious lower respiratory tract (lung) disease caused by respiratory syncytial virus (RSV) that would require hospitalisation.
Estonian: Synagist kasutatakse respiratoorse süntsütiaalviiruse (RSV) põhjustatud ja haiglaravi vajava raske alumiste hingamisteede haiguse (kopsuhaiguse) ennetamiseks.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen).
Estonian: Synagise toimeaine palivisumaab on monoklonaalne antikeha (teatud valk), mis tunneb ära teatud antigeeni (organismis leiduva spetsiifilise struktuuri) ja seondub sellega.
English: The main study of Synagis was carried out in 1,502 high-risk children and compared Synagis with placebo (a dummy treatment) during one RSV season.
Estonian: Synagise põhiuuringus osales 1502 suure riskiga last ja selles võrreldi Synagise toimet ühe respiratoorse süntsütiaalviiruse hooaja vältel platseebo (näiva ravimi) toimega.
English: What is Synagis?
Estonian: Mis on Synagis?
English: Synagis is a powder and solvent that are made up into a solution for injection.
Estonian: Synagis on pulber ja lahusti, millest valmistatakse süstelahus.
English: What is Synagis used for?
Estonian: Milleks Synagist kasutatakse?
English: In both studies, the main measure of effectiveness was the number of children who had to be admitted to hospital because of RSV infection.The effects of Synagis were first tested in experimental models before being studied in humans.
Estonian: Mõlemas uuringus oli efektiivsuse põhinäitaja respiratoorse süntsütiaalviiruse nakkuse tõttu haiglaravi vajanud laste arv.
English: What benefit has Synagis shown during the studies?
Estonian: Milles seisneb uuringute põhjal Synagise kasulikkus?
English: How is Synagis used?
Estonian: Kuidas Synagist kasutatakse?
English: How has Synagis been studied?
Estonian: Kuidas Synagist uuriti?
English: How does Synagis work?
Estonian: Kuidas Synagis toimib?
English: Palivizumab has been designed to attach to a protein called ‘fusion protein A' on the surface of RSV.
Estonian: Palivisumaab seondub respiratoorse süntsütiaalviiruse pinnal oleva teatud valguga (nn sulandvalguga A).
English: Synagis was more effective than placebo in reducing RSV-related hospitalisations: 5% of the children who received Synagis were admitted to hospital for RSV infection during the study, compared with 11% of those who received placebo.
Estonian: Respiratoorse süntsütiaalviiruse nakkuse tõttu vajas uuringu ajal haiglaravi Synagist saanud lastest 5% ja platseebot saanutest 11%.
English: Date of first authorisation: 26 August 2010 Date of latest renewal: 19 June 2015
Estonian: Müügiloa esmase väljastamise kuupäev: 26. august 2010 Müügiloa viimase uuendamise kuupäev: 19. juuni 2015
English: Extension Study 044
Estonian: Jätku-uuring 044
English: • Patient evaluation and selection;
Estonian: • patsiendi hindamine ja valik;
English: Ask your pharmacist how to throwaway medicines you no longer use.
Estonian: Küsige oma apteekrilt, kuidas visata ära ravimeid, mida te enam ei kasuta.
English: Elderly (≥65 years old)
Estonian: Eakad (≥ 65 aasta vanused)
English: There are 5 potential N-linked glycosylation sites, four of which are occupied.
Estonian: On olemas 5 potentsiaalset N-seotud glükosülatsioonikohta, millest neli on hõivatud.
English: VPRIV should not be used in children under the age of 2 years.
Estonian: VPRIV'i ei tohi kasutada alla 2 aasta vanustel lastel.
English: In some cases vomiting can be serious (reported from post-marketing experience).
Estonian: Mõnel juhul võib oksendamine olla raske (teatatud turuletulekujärgselt).
English: However, no data are available for children under the age of 4 years.
Estonian: Alla 4 aasta vanuste laste kohta siiski andmed puuduvad.
English: From a microbiological point of view, the medicinal product should be used immediately.
Estonian: Mikrobioloogilisest aspektist lähtuvalt tuleb ravim kohe ära kasutada.
English: 400 Units
Estonian: 400 ühikut
English: Home administration under the supervision of a healthcare professional may be considered only for those patients who have received at least three infusions and were tolerating their infusions well.
Estonian: Kodust manustamist tervishoiutöötaja järelevalve all võib kaaluda ainult patsientide puhul, kes on saanud vähemalt kolm infusiooni ja talusid infusioone hästi.
English: • Emergency plan provided by the prescriber including who to call and what to do in the case of a serious hypersensitivity reaction.
Estonian: • ravi väljakirjutaja poolt väljastatav hädaolukorra kava, sealhulgas, kellele helistada ja mida teha tõsise ülitundlikkusreaktsiooni tekkimisel.
English: - You may be given additional medicines to treat or help prevent future reactions.
Estonian: - Teile võidakse anda lisaks ravimeid, mis seda ravivad või aitavad edasisi reaktsioone ennetada.
English: The required vials are removed from the refrigerator.
Estonian: Vajalik arv viaale võetakse külmkapist välja.
English: These are called infusion-related reactions and may affect more than 1 in 10 people (very common).
Estonian: Neid nimetatakse infusiooniga seotud reaktsioonideks ja neid võib esineda rohkem kui 1 inimesel 10st (väga sage).
English: • Description on how to prepare and administer the infusion including safety information;
Estonian: • kirjeldus, kuidas infusiooni ette valmistada ja manustada, sealhulgas ohutusalane teave;
English: Most side effects occurred during the infusion or shortly after.
Estonian: Enamik kõrvaltoimeid tekkis infusiooni ajal või veidi pärast seda.
English: Fertility Animal studies show no evidence of impaired fertility.
Estonian: Fertiilsus Loomkatsed ei näita kahjulikku toimet fertiilsusele.
English: Your doctor will monitor your response to treatment and may change your dose (up or down) over time.
Estonian: Arst jälgib teie ravivastust ja võib aja jooksul teie annust muuta (suurendada või vähendada).
English: The studies allowed the inclusion of patients 2 years and older and the safety and efficacy profiles are expected to be similar down to the age of 2 years.
Estonian: Uuringutesse lubati võtta 2-aastaseid ja vanemaid patsiente ning alates 2 aasta vanusest on ohutuse ja efektiivsuse profiilid eeldatavalt sarnased.
English: Some solution will remain in the vial:
Estonian: Osa lahusest jääb viaali:
English: All patients received at least 2 years of ERT and were followed for a mean of 4.5 years (min. 2.3 years, max 5.8 years).
Estonian: Kõik patsiendid said vähemalt 2 aastat ensüümasendusravi ja neid jälgiti keskmiselt 4,5 aastat (min 2,3 aastat, max 5,8 aastat).
English: VPRIV should not be infused with other medicines in the same infusion as the compatibility in solution with other medicines has not been evaluated.
Estonian: VPRIV'i ei tohi infundeerida sama infusiooni käigus koos teiste ravimitega, sest sobivust lahuses koos teiste ravimitega ei ole hinnatud.
English: These medicines may include antihistamines, antipyretics, and corticosteroids.
Estonian: Need ravimid võivad olla näiteks antihistamiinsed ained, antipüreetikumid ja kortikosteroidid.
English: • Requirements for home infusion (home condition, patient assessment, emergency treatment);
Estonian: • nõuded kodus infundeerimiseks (kodused tingimused, patsiendi hindamine, ravi hädaolukorras);
English: After preparation, your doctor or nurse will give the medicine to you through a drip into a vein (by intravenous infusion) over a period of 60 minutes.
Estonian: Pärast valmistamist manustab arst või õde teile ravimit tilguti kaudu veeni (intravenoosse infusioonina) 60 minuti jooksul.
English: 57 patients were treatment-naïve.
Estonian: 57 patsienti ei olnud varem ravitud.
English: ** produced in an HT-1080 human fibroblast cell line by recombinant DNA technology.
Estonian: **Valmistatakse rekombinantse DNA tehnoloogia abil inimese fibroplastide rakuliinis HT-1080.
English: Drug Substance Manufacture Shire Human Genetic Therapies, Inc 400 Shire Way, Lexington, Massachusetts 02421 USA
Estonian: Drug Substance Manufacture Shire Human Genetic Therapies, Inc 400 Shire Way, Lexington, Massachusetts 02421 Ameerika Ühendriigid
English: Velaglucerase alfa is a glycoprotein.
Estonian: Alfavelaglütseraas on glükoproteiin.
English: Doses higher than 60 Units/kg have not been studied.
Estonian: Annuseid üle 60 ühiku/kg ei ole uuritud.
English: The infusion should be initiated within 24 hours from the time of reconstitution.
Estonian: Infusiooni tuleb alustada 24 tunni jooksul alates lahustamisest.
English: Overall velaglucerase alfa group (N=39)
Estonian: Üldine alfavelaglütseraasi rühm (N = 39)
English: Information is presented by system organ class and frequency according to MedDRA convention.
Estonian: Teave on esitatud organsüsteemide ja esinemissageduse järgi, kasutades MedDRA termineid.
English: • Infusion diary;
Estonian: • infusioonide päevik;
English: Pre-treatment with antihistamines and/or corticosteroids may prevent subsequent reactions in those cases where symptomatic treatment was required.
Estonian: Eelravi antihistamiinide ja/või kortikosteroididega võib aidata hoida ära edasisi reaktsioone, juhul kui on vajalik sümptomaatiline ravi.
English: The effect on height was assessed in the study 044 (see section 5.1, Extension Study 044).
Estonian: Toimet kehapikkusele hinnati uuringus 044 (vt lõik 5.1 „Jätku-uuring 044“).
English: Cell Bank storage and Drug Substance Manufacture Shire Human Genetic Therapies, Inc 205 Alewife Brook Parkway, Cambridge, Massachusetts 02138 USA
Estonian: Cell Bank storage and Drug Substance Manufacture Shire Human Genetic Therapies, Inc 205 Alewife Brook Parkway, Cambridge, Massachusetts 02138 Ameerika Ühendriigid
English: What VPRIV looks like and contents of the pack
Estonian: Kuidas VPRIV välja näeb ja pakendi sisu
English: - if you are severely allergic to velaglucerase alfa or any of the other ingredients of this medicine (listed in section 6).
Estonian: - kui te olete alfavelaglütseraasi või selle ravimi mis tahes koostisosa (loetletud lõigus 6) suhtes tugevalt allergiline.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products - enzymes, ATC code: A16AB10.
Estonian: Farmakoterapeutiline rühm: muud seedekulgla ja ainevahetuse ravimid - ensüümid, ATC-kood: A16AB10.
English: The safety profile in these patients was similar to that observed in other clinical trials.
Estonian: Nende patsientide ohutusprofiil sarnanes teistes kliinilistes uuringutes täheldatule.
English: The steady state volume of distribution was approximately 10% of the body weight.
Estonian: Jaotusmaht püsikontsentratsioonil moodustas ligikaudu 10% kehamassist.
English: Dose adjustments can be made on an individual basis based on achievement and maintenance of therapeutic goals.
Estonian: Annuseid võib individuaalselt kohandada olenevalt ravieesmärkide saavutamisest ja alalhoidmisest.
English: Other medicines and VPRIV
Estonian: Muud ravimid ja VPRIV
English: Severe allergic reaction to the active substance or to any of the excipients listed in section 6.1.
Estonian: Raske allergiline reaktsioon toimeaine või lõigus 6.1 loetletud mis tahes abiaine suhtes.
English: The safety and efficacy profiles were similar between paediatric and adult patients.
Estonian: Pediaatriliste ja täiskasvanud patsientide ohutuse ja efektiivsuse profiilid olid sarnased.
English: Read all of this leaflet carefully before this medicine is used because it contains important information for you.
Estonian: Enne ravimi kasutamist lugege hoolikalt infolehte, sest siin on teile vajalikku teavet.
English: Tell your doctor if you have previously experienced an infusion-related reaction with other ERT for Gaucher disease.
Estonian: Öelge oma arstile, kui teil on varem tekkinud infusiooniga seotud reaktsioon mõne Gaucher' tõve puhul kasutatud ensüümasendusravi suhtes.