FrancophonIA/ELRC3.0 huggingface dataset:
English: • hypertension
Estonian: ● hüpertensioon
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL (0.5 g and 2.5 g)
Estonian: VIAALI ETIKETT (0,5 g ja 2,5 g)
English: The recommended starting dose is 0.4 - 0.8 g/kg given once followed by at least 0.2 g/kg given every three to four weeks.
Estonian: Alustamiseks on soovitatav ühekordne annus 0,4...0,8 g/kg, seejärel 0,2 g/kg iga kolme kuni nelja nädala järel.
English: ● chest discomfort/chest pain
Estonian: ● ebamugavustunne rinnus, valu rinnus
English: • chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain
Estonian: • külmavärinad, peavalu, pearinglus, palavik, oksendamine, allergilised reaktsioonid, iiveldus,
English: Certain adverse reactions (e.g. headache, flushing, chills, myalgia, wheezing, tachycardia, lower back pain, nausea, and hypotension) may be related to the rate of infusion.
Estonian: Teatud kõrvaltoimednagu peavalu, õhetus, külmavärinad, müalgia, vilistav hingamine, tahhükardia, alaseljavalu, iiveldus ja hüpotensioon võivad olla seotud infusioonikiirusega.
English: In patients at risk for thromboembolic adverse reactions, IVIg products should be administered at the minimum rate of infusion and dose practicable.
Estonian: Trombemboolsete kõrvaltoimete riskiga patsientidel tuleb IVIg preparaate manustada minimaalsel infusioonikiirusel tavapärases annuses.
English: Each vial of 10 ml contains: 0.5 g of human normal immunoglobulin Each vial of 50 ml contains: 2.5 g of human normal immunoglobulin Each vial of 100 ml contains: 5 g of human normal immunoglobulin Each vial of 200 ml contains: 10 g of human normal immunoglobulin Each vial of 400 ml contains: 20 g of human normal immunoglobulin
Estonian: Iga 10 ml viaal sisaldab: 0,5 g inimese normaalimmunoglobuliini Iga 50 ml viaal sisaldab: 2,5 g inimese normaalimmunoglobuliini Iga 100 ml viaal sisaldab: 5 g inimese normaalimmunoglobuliini Iga 200 ml viaal sisaldab: 10 g inimese normaalimmunoglobuliini Iga 400 ml viaal sisaldab: 20 g inimese normaalimmunoglobuliini
English: Flebogamma DIF contains sorbitol
Estonian: Flebogamma DIF sisaldab sorbitooli
English: • Cases of transient cutaneous reactions (side effects on your skin).
Estonian: • Mööduvate nahareaktsioonide juhtumid (nahal avalduvad kõrvaltoimed).
English: The dose interval when steady state has been reached varies from 3 - 4 weeks.
Estonian: Manustamisintervall pärast tasakaalu saavutamist on kolm kuni neli nädalat.
English: Secondary immunodeficiencies
Estonian: Primaarsed immuunpuudulikkuse sündroomid
English: It was observed that the proportion of headache, fever, heart rate increased and low blood pressure in children was higher than in adults.
Estonian: Lastel täheldati peavalu, palaviku, südame löögisageduse kiirenemise ja madala vererõhu suuremat osakaalu kui täiskasvanutel.
English: Paediatric population It is recommended to monitor vital signs when administering Flebogamma DIF to paediatric patients.
Estonian: Flebogamma DIF-i manustamisel lastele on soovitatav jälgida patsiendi elutähtsaid näitajaid.
English: Dose based on body weight may require adjustment in underweight or overweight patients.
Estonian: Ala- või ülekaalulistel patsientidel võib osutuda vajalikuks kehakaalul põhinevat annust muuta.
English: Asthma, Cough, Dyspnoea, Epistaxis, Nasal discomfort, Laryngeal pain
Estonian: Astma, köha, düspnoe, ninaverejooks, ebamugavustunne ninas, kõrivalu
English: Radiculopathy, Syncope
Estonian: Radikulopaatia, sünkoop Aeg-ajalt
English: How to use Flebogamma DIF
Estonian: Kuidas Flebogamma DIF'i kasutada
English: It was observed that the proportion of headache, chills, pyrexia, nausea, vomiting, hypotension, heart rate increase and back pain in children was higher than in adults.
Estonian: Lastel täheldati peavalu, külmavärinate, palaviku, iivelduse, oksendamise, hüpotensiooni, südametegevuse kiirenemise ja seljavalu suuremat osakaalu kui täiskasvanutel.
English: Rare (may affect up to 1 in 1000 infusions):
Estonian: • Harv (võib esineda kuni 1 infusioonil 1000st):
English: It was observed that the proportion of headache, chills, fever, nausea, vomiting, low blood pressure, heart rate increase and back pain in children was higher than in adults.
Estonian: Lastel täheldati peavalu, külmavärinate, palaviku, iivelduse, oksendamise, madala vererõhu, südame löögisageduse kiirenemise ja seljavalu suuremat osakaalu kui täiskasvanutel.
English: ● feeling cold
Estonian: ● vappekülm või külmavärinad
English: ● tremor (to tremble)
Estonian: ● treemor (värinad)
English: ● haematoma
Estonian: ● nägemise hägustumine
English: What Flebogamma DIF is used for
Estonian: Milleks Flebogamma DIF'i kasutatakse
English: 0.2 - 0.8 g/kg every 3 - 4 weeks
Estonian: Säilitusannus: 0,2...0,8 g/kg iga 3 kuni 4 nädala järel
English: ● limb discomfort
Estonian: ● lihaste-luustiku ebamugavustunne
English: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
Estonian: Krooniline põletikuline demüeliniseeriv polüradikuloneuropaatia
English: Each vial of 50 ml contains: 5 g of human normal immunoglobulin Each vial of 100 ml contains: 10 g of human normal immunoglobulin Each vial of 200 ml contains: 20 g of human normal immunoglobulin Distribution of the IgG subclasses (approx. values): IgG1 66.6%
Estonian: Inimese normaalimmunoglobuliin................. 100 mg (puhtusaste vähemalt 97% IgG-d) Iga 50 ml viaal sisaldab 5 g inimese normaalimmunoglobuliini Iga 100 ml viaal sisaldab 10 g inimese normaalimmunoglobuliini Iga 200 ml viaal sisaldab 20 g inimese normaalimmunoglobuliini IgG alaliikide osakaal (ligikaudused väärtused): IgG1 66,6%
English: Bicytopenia, Leukopenia
Estonian: Bitsütopeenia, leukopeenia Aeg-ajalt
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL LABEL (5 g, 10 g and 20 g)
Estonian: SISEPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED VIAALI ETIKETT (5 g, 10 g ja 20 g)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/404/006-008
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/07/404/006-008
English: Rare
Estonian: Sobimatus
English: Renal and urinary disorders Urinary retention
Estonian: Neerude ja kuseteede häired Uriinipeetus
English: Bronchitis, Wheezing
Estonian: Bronhiit, vilistav hingamine Sage
English: How to store Flebogamma DIF
Estonian: Kuidas Flebogamma DIF'i säilitada
English: ● urticaria
Estonian: ● kaelavalu
English: Potential complications can often be avoided by ensuring that patients: - are not sensitive to human normal immunoglobulin by initially injecting the product slowly (at an initial rate of 0.01 - 0.02 ml/kg/min) - are carefully monitored for any symptoms throughout the infusion period.
Estonian: Selleks manustatakse ravimit esialgu aeglaselt (0,01...0,02 ml/kg/minutis); - infusiooni kestel jälgitakse patsienti hoolikalt võimalike kõrvaltoimete esinemise suhtes.
English: NAME OF THE MEDICINAL PRODUCT Flebogamma DIF 100 mg/ml solution for infusion
Estonian: RAVIMPREPARAADI NIMETUS Flebogamma DIF 100 mg/ml infusioonilahus.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/404/001-005
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/07/404/001-005
English: If tolerated, advance to 0.02 ml/kg/min for the second 30 minutes.
Estonian: Kui see on talutav, tõstke kiirus järgnevaks 30 minutiks 0,02 ml/kg/min peale.
English: The product is also used in patients at high risk of bleeding or prior to surgery to correct the platelet count.
Estonian: Seda preparaati kasutatakse ka vereliistakute hulga korrigeerimiseks operatsioonieelselt neil patsientidel, kellel on kõrge risk verejooksudeks.
English: • blood pressure increased
Estonian: ● vererõhu tõus
English: ● myalgia (muscle pain)
Estonian: ● müalgia (lihasvalu)
English: ● malaise
Estonian: ● närvilisus
English: The dose may need to be individualised for each patient dependent on the clinical response.
Estonian: Sõltuvalt kliinilisest vastusest võib osutuda vajalikuks annuse individuaalne kohandamine igale patsiendile.
English: The dosing and intervals may have to be adapted according to the individual course of the disease.
Estonian: Olenevalt haiguse individuaalsest kulust võib osutuda vajalikuks annustamist ja intervalle kohandada.
English: ● haemoglobin decreased
Estonian: ● langenud hemoglobiinitase
English: ● injection site reaction
Estonian: ● reaktsioon süstekohal
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (5 g, 10 g and 20 g)
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED KARP (5 g, 10 g ja 20 g)
English: Potential complications can often be avoided by ensuring that patients: - are not sensitive to human normal immunoglobulin by initially injecting the product slowly (at an initial rate of 0.01 ml/kg/min) - are carefully monitored for any symptoms throughout the infusion period.
Estonian: Selleks manustatakse ravimit esialgu aeglaselt (0,01 ml/kg/minutis); - infusiooni kestel jälgitakse patsienti hoolikalt võimalike kõrvaltoimete esinemise suhtes.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for infusion
Estonian: RAVIMVORM JA PAKENDI SUURUS Infusioonilahus
English: Starting dose: 2 g/kg divided over 2 - 5 consecutive days.
Estonian: Algannus: 2 g/kg jagatuna 2...5 järjestikuse päeva peale.
English: • nasopharyngitis
Estonian: • uriinipeetus
English: Flebogamma DIF 50 mg/ml solution for infusion Human normal immunoglobulin (IVIg)
Estonian: Flebogamma DIF 50 mg/ml infusioonilahus Inimese normaalimmunoglobuliin (IVIg)
English: NAME OF THE MEDICINAL PRODUCT Flebogamma DIF 50 mg/ml solution for infusion
Estonian: RAVIMPREPARAADI NIMETUS Flebogamma DIF 50 mg/ml infusioonilahus.
English: In particular, patients naive to human normal immunoglobulin, patients switched from an alternative IVIg product or when there has been a long interval since the previous infusion should be monitored at the hospital during the first infusion and for the first hour after the first infusion, in order to detect potential adverse signs.
Estonian: Eriti hoolega tuleb esimese infusiooni ajal ja esimese tunni järel pärast manustamist jälgida haiglas esmakordselt immunoglobuliini saavaid, immunoglobuliini preparaati vahetanud või pika manustamisintervalliga patsiente.
English: ● vomiting
Estonian: ● oksendamine
English: STATEMENT OF ACTIVE SUBSTANCE(S) One ml contains 50 mg of human normal immunoglobulin (IVIg) of which at least 97% is IgG.
Estonian: TOIMEAINE(TE) SISALDUS Üks ml sisaldab 50 mg inimese normaalimmunoglobuliini (IVIg), millest vähemalt 97% on IgG.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One ml contains 100 mg of human normal immunoglobulin (IVIg) of which at least 97% is IgG.
Estonian: TOIMEAINE(TE) SISALDUS Üks ml sisaldab 100 mg inimese normaalimmunoglobuliini (IVIg), millest vähemalt 97% on IgG.
English: Primary immune thrombocytopenia
Estonian: Primaarne immuunne trombotsütopeenia
English: ● arthralgia (joint pain)
Estonian: ● artralgia (liigesvalu)
English: Chronic inflammatory demyelinating polyneuropathy (CIDP)
Estonian: Krooniline põletikuline demüeliniseeriv polüneuropaatia
English: ● urinary infection
Estonian: ● uroinfektsioon
English: Flebogamma DIF 50 mg/ml should be infused intravenously at an initial rate of 0.01 - 0.02 ml/kg/min for the first thirty minutes.
Estonian: Esmalt soovitatakse Flebogamma DIF 50 mg/ml infusioonilahust manustada veeni esimese 30 minuti jooksul kiirusega 0,01...0,02 ml/kg/min.
English: Elderly
Estonian: Iiveldus
English: • migraine
Estonian: ● peavalu
English: NAME OF THE MEDICINAL PRODUCT Flebogamma DIF 100 mg/ml solution for infusion Human normal immunoglobulin (IVIg)
Estonian: RAVIMPREPARAADI NIMETUS Flebogamma DIF 100 mg/ml infusioonilahus Inimese normaalimmunoglobuliin (IVIg)
English: Again, if tolerated, advance to 0.04 ml/kg/min for the third 30 minutes.
Estonian: Kui see on talutav, tõstke kiirus järgnevaks 30 minutiks 0,04 ml/kg/min peale.
English: ● diarrhoea
Estonian: ● kõhulahtisus
English: Tabulated list of adverse reactions
Estonian: Kõrvaltoimete nimekirja tabel
English: Wheezing
Estonian: Segasus
English: Each ml of this medicinal product contains 50 mg of sorbitol.
Estonian: See ravimpreparaat sisaldab ühe ml kohta 50 mg sorbitooli.
English: Talk to your doctor, pharmacist or nurse before using Flebogamma DIF.
Estonian: Enne Flebogamma DIF'i kasutamist pidage nõu oma arsti, apteekri või meditsiiniõega.
English: ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l *PSAF= failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines
Estonian: * Tõestatud spetsiifilise antikeha puudulikkus (proven specific antibody failure, PSAF) = IgG antikeha tiiter ei tõuse vähemalt kahekordseks pneumokoki antigeeni polüsahhariid- ja polüpeptiid vaktsiinide suhtes
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/404/006
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/07/404/006
English: There are five groups:
Estonian: Need patsiendid võib jagada viide rühma:
English: One ml contains 100 mg of human normal immunoglobulin (IVIg) of which at least 97% is IgG.
Estonian: Üks ml sisaldab 100 mg inimese normaalimmunoglobuliini (IVIg), millest vähemalt 97% on IgG.
English: The ability to drive and operate machines may be impaired by some adverse reactions, such as dizziness, associated with Flebogamma DIF.
Estonian: Mõned Flebogamma DIF-i kasutamisega seostatud kõrvaltoimed, nagu näiteks pearinglus, võivad mõjutada auto juhtimise ja masinate käsitsemise võimet.
English: One ml contains 50 mg of human normal immunoglobulin (IVIg) of which at least 97% is IgG.
Estonian: Üks ml sisaldab 50 mg inimese normaalimmunoglobuliini (IVIg), millest vähemalt 97% on IgG.
English: • nasal discomfort
Estonian: • ebamugavustunne ninas
English: Maintenance dose:
Estonian: KÕLBLIKKUSAEG Kõlblik kuni:
English: Cardiovascular disorder
Estonian: Südame häired
English: Flebogamma DIF 100 mg/ml solution for infusion Human normal immunoglobulin (IVIg)
Estonian: Flebogamma DIF-i 100 mg/ml infusioonilahus Inimese normaalimmunoglobuliin (IVIg)
English: • injection site reactions (including injection site oedema, pain, pruritus and swelling)
Estonian: • reaktsioonid süstekohal (sealhulgas turse, valu, sügelus ja paistetus süstekohal)
English: Seek medical care with no delay if any of the following side effects happen during or after the infusion:
Estonian: Kui teil tekib infusiooni ajal või pärast seda ükskõik milline kõrvaltoime, teatage kohe tervishoiutöötajale:
English: Loop diuretics Avoidance of concomitant use of loop diuretics
Estonian: Lingudiureetikumid Vältida tuleb lingudiureetikumide samaaegselt kasutamist.
English: Solution for infusion.
Estonian: Infusioonilahus.
English: Chills, Injection site reaction, Pain, Rigors
Estonian: Külmavärinad, reaktsioon süstekohal, valu, vappekülm Sage
English: NAME OF THE MEDICINAL PRODUCT Flebogamma DIF 50 mg/ml solution for infusion Human normal immunoglobulin (IVIg)
Estonian: RAVIMPREPARAADI NIMETUS Flebogamma DIF 50 mg/ml infusioonilahus Inimese normaalimmunoglobuliin (IVIg)
English: One ml contains 100 mg of human normal immunoglobulin, of which at least 97% is IgG.
Estonian: Üks ml sisaldab 100 mg inimese normaalimmunoglobuliini, millest vähemalt 97% on IgG.
English: ● influenza like illness
Estonian: ● gripilaadne haigus
English: ● red blood cells and white blood cells decreased
Estonian: ● vere puna- ja valgeliblede vähenemine
English: ● maculopathy (illness of the macula, in the retina of the eyes)
Estonian: ● makulopaatia (silmade võrkkesta tähni haigus)
English: Abdominal pain upper, Abdominal pain, Diarrhoea, Nausea, Vomiting Common
Estonian: Ülakõhuvalu, kõhuvalu, kõhulahtisus, iiveldus, oksendamine
English: Indication
Estonian: Näidustus
English: One ml contains 50 mg of human normal immunoglobulin, of which at least 97% is IgG.
Estonian: Üks ml sisaldab 50 mg inimese normaalimmunoglobuliini, millest vähemalt 97% on IgG.
English: • pruritus (itching)
Estonian: • asteenia (kurnatus)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/404/001
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/07/404/001
English: ● flatulence
Estonian: ● iiveldus
English: Transmissible agents
Estonian: Haigustekitajate ülekandmine
English: Device dislocation
Estonian: Seedetrakti häired
English: ● rash
Estonian: ● lööve
English: Flebogamma DIF should be infused intravenously at an initial rate of 0.01 ml/kg/min for the first thirty minutes.
Estonian: Esmalt soovitatakse Flebogamma DIF'i infusioonilahust manustada veeni esimese 30 minuti jooksul kiirusega 0,01 ml/kg/min.
English: Ear and labyrinth disorders Vertigo
Estonian: Kõrva ja labürindi häired Vertiigo
English: Fertility
Estonian: Rasedus
English: 0.8 - 1 g/kg or
Estonian: Säilitusannus: 1 g/kg või
English: • overweight
Estonian: • ülekaal
English: Epistaxis, Nasal congestion, Upper-airway cough syndrome, Sinus pain, Dyspnoea
Estonian: Ninaverejooks, ninakinnisus, ülemiste hingamisteede köhasündroom, ninakõrvalurgete valu, düspnoe
English: *PSAF= failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines.
Estonian: * Tõestatud spetsiifilise antikeha puudulikkus (proven specific antibody failure, PSAF) = IgG antikeha tiiteri ei tõuse vähemalt kahekordseks pneumokoki antigeeni polüsahhariid- ja polüpeptiid vaktsiinide suhtes.
English: Insomnia, Restlessness
Estonian: Psühhiaatrilised häired Unetus, rahutus
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Flebogamma DIF 50 mg/ml solution for infusion Human normal immunoglobulin (IVIg)
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE Flebogamma DIF 50 mg/ml infusioonilahus Inimese normaalimmunoglobuliin (IVIg) Intravenoosne
English: ● upper-airway cough syndrome
Estonian: ● ülemiste hingamisteede köha sündroom
English: Headache
Estonian: Kõrvavalu
English: ● heart rate decreased
Estonian: ● südame löögisageduse aeglustumine
English: ● erythema (redness of the skin)
Estonian: ● erüteem (nahapunetus)
English: Dizziness
Estonian: ABIAINED
English: Body temperature increased
Estonian: Kehatemperatuuri tõus
English: • epistaxis (haemorrhage from the nose)
Estonian: ● pearinglus (merehaigus)
English: ● muscle spasms and muscle tightness
Estonian: ● lihasspasmid ja lihaspinge
English: ● pruritus
Estonian: ● sügelus
English: ● dyspnoea (difficulty in breathing)
Estonian: • hingeldus (hingamisraskus)
English: The recommended dose is 0.2 - 0.4 g/kg every three to four weeks.
Estonian: Sekundaarsed immuunpuudulikkused (määratletud lõigus 4.1) Soovitatav annus on 0,2...0,4 g/kg iga kolme kuni nelja nädala järel.
English: • muscle spasms
Estonian: ● tsüanoos (naha sinakus)
English: ● postnasal drip (excessive mucus)
Estonian: ● ninatilkumine (liigne lima)
English: Abdominal discomfort, Abdominal distension, Dry mouth, Haematemesis Uncommon
Estonian: Jäsemete ebamugavustunne, lihasspasmid, lihaspinged, kaelavalu, jäsemevalu
English: Conjunctivitis, Maculopathy, Vision blurred
Estonian: Konjunktiviit, makulopaatia, nägemise hägustumine
English: Flebogamma DIF should be infused intravenously at an initial rate of 0.01 - 0.02 ml/kg/min for the first thirty minutes.
Estonian: Esmalt soovitatakse Flebogamma DIF'i infusioonilahust manustada veeni esimese 30 minuti jooksul kiirusega 0,01...0,02 ml/kg/min.
English: ● hypersensitivity
Estonian: ● ülitundlikkus
English: What measures are being taken to ensure the safe and effective use of Prevymis?
Estonian: Mis meetmed võetakse, et tagada Prevymise ohutu ja efektiivne kasutamine?
English: Prevymis letermovir
Estonian: Prevymis letermoviir
English: The usual recommended dose by mouth or as an infusion is 480 mg once daily.
Estonian: Tavapärane soovitatav suukaudne või infusioonina manustatav annus on 480 mg üks kord ööpäevas.
English: The European Medicines Agency therefore decided that Prevymis's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Seetõttu otsustas Euroopa Ravimiamet, et Prevymise kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: Many people have CMV in their body but it is usually inactive and it does not cause harm.
Estonian: Paljudel inimestel on tsütomegaloviirus organismis, kuid tavaliselt on see inaktiivne ega kahjusta inimest.
English: What is Prevymis and what is it used for?
Estonian: Mis on Prevymis ja milleks seda kasutatakse?
English: All patients in this study were CMV seropositive, meaning they had come into contact with the virus before and were likely to be carrying it in an inactive form.
Estonian: Kõik selles uuringus osalenud patsiendid olid tsütomegaloviiruse suhtes seropositiivsed, mis tähendab, et patsiendid olid selle viirusega varem kokku puutunud ning tõenäoliselt esines neil mitteaktiivse vormi kandlus.
English: Treatment with Prevymis is started on the day of the transplant or on any day up to 28 days afterwards and it is continued for 100 days after the transplantation; longer treatment may be considered in some patients.
Estonian: Ravi Prevymisega alustatakse siirdamise päeval või mis tahes päeval kuni 28 päeva jooksul pärast siirdamist ja jätkatakse 100 päeva jooksul pärast siirdamist.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Prevymis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Estonian: Harvikravimite komitee arvamuse kokkuvõte Prevymise kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Prevymis have been included in the summary of product characteristics and the package leaflet.
Estonian: Prevymise ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Of the patients receiving Prevymis, about 38% (122 out of 325) had signs of CMV becoming active 24 weeks after the stem cell transplant compared with 61% of the patients (103 out of 170) receiving placebo.
Estonian: Prevymist saanud patsientidest esines tsütomegaloviiruse aktivatsiooni tunnuseid 24 nädalat pärast tüvirakkude siirdamist ligikaudu 38%-l (122 patsienti 325st), samas kui platseebot kasutanud patsientidest esines tsütomegaloviiruse aktivatsiooni tunnuseid 61%-l (103 patsienti 170st).
English: The combination of Prevymis and ciclosporin must not be used with dabigatran, atorvastatin, pitavastatin, rosuvastatin and simvastatin.
Estonian: Prevymise ja tsüklosporiini kombinatsiooni ei tohi kasutada koos dabigatraani, atorvastatiini, pitavastatiini, rosuvastatiini ja simvastatiiniga.
English: Why is Prevymis approved?
Estonian: Miks Prevymis heaks kiideti?
English: The full EPAR for Prevymis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Prevymise kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The most common side effects with Prevymis (which may affect up to 1 in 10 people) are nausea (feeling sick), diarrhoea and vomiting.
Estonian: Prevymise kõige sagedamad kõrvalnähud (võivad esineda kuni 1 patsiendil 10st) on iiveldus, kõhulahtisus ja oksendamine.
English: If ciclosporin (a medicine that prevents rejection of the transplant) is used at the same time, the Prevymis dose is reduced to 240 mg once daily.
Estonian: Kui samaaegselt kasutatakse tsüklosporiini (siiriku äratõuget ennetavat ravimit), vähendatakse Prevymise annust 240 mg-ni ööpäevas.
English: By blocking the enzyme, the medicine prevents viruses from developing properly, so that CMV cannot multiply and infect other cells.
Estonian: Ensüümi blokeerides ennetab ravim viiruse õiget teket, et tsütomegaloviirus ei suudaks paljuneda ja teisi rakke nakatada.
English: Prevymis must not be used together with the medicine pimozide, or ergot medicines such as ergotamine and dihydroergotamine.
Estonian: Prevymist ei tohi kasutada koos ravimiga pimosiid või ergotamiini analoogidega, nagu ergotamiin ja dihüdroergotamiin.