FrancophonIA/ELRC3.0 huggingface dataset:
English: Metotrexat Astron Methotrexate 22.5mg/0.45ml
Estonian: Metotrexat Astron Metotreksaati 22.5mg/0.45ml
English: Methotrexate Disodium 2.5mg Tablet
Estonian: Metotreksaati Disodium 2.5mg Tablet
English: Метожект Pen Methotrexate 27.5mg/0.55ml
Estonian: Метожект Pen Metotreksaati 27.5mg/0.55ml
English: Methotrexate Gry Methotrexate Disodium 5.48mg/2ml
Estonian: Methotrexate Gry Metotreksaati Disodium 5.48mg/2ml
English: Methotrexate Gry Methotrexate Disodium 5483.7mg/50ml
Estonian: Methotrexate Gry Metotreksaati Disodium 5483.7mg/50ml
English: Metotrexat Astron Methotrexate 27.5mg/0.55ml
Estonian: Metotrexat Astron Metotreksaati 27.5mg/0.55ml
English: Methotrexaat Pch Methotrexate 2.5mg Tablet
Estonian: Methotrexaat Pch Metotreksaati 2.5mg Tablet
English: Belgium Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)
Estonian: Prantsusmaa Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)
English: Metotrexat Astron Methotrexate 15mg/0.3ml
Estonian: Metotrexat Astron Metotreksaati 15mg/0.3ml
English: Methotrexat Gry Methotrexate Disodium 54.84mg/2ml
Estonian: Methotrexat Gry Metotreksaati Disodium 54.84mg/2ml
English: Metotreksat Ebewe Methotrexate 10mg Tablet
Estonian: Metotreksat Ebewe Metotreksaati 10mg Tablet
English: Methotrexate 0.5ml/25mg
Estonian: Metotreksaati 0.5ml/25mg
English: Methotrexate Teva Methotrexate 50mg/2ml
Estonian: Methotrexate Teva Metotreksaati 50mg/2ml
English: Metotreksat Ebewe Methotrexate 2.5mg Tablet
Estonian: Metotreksat Ebewe Metotreksaati 2.5mg Tablet
English: Methotrexat Ebewe Methotrexate Disodium 21.94mg/Ml
Estonian: Methotrexat Ebewe Metotreksaati Disodium 21.94mg/Ml
English: Methotrexate Disodium 21.94mg/Ml
Estonian: Metotreksaati Disodium 21.94mg/Ml
English: Methotrexate Disodium 8.22mg/Ml
Estonian: Metotreksaati Disodium 8.22mg/Ml
English: Methotrexate Orion Methotrexate 2.5mg Tablet
Estonian: Methotrexate Orion Metotreksaati 2.5mg Tablet
English: Methotrexate Cipla Methotrexate 10mg Tablet
Estonian: Methotrexate Cipla Metotreksaati 10mg Tablet
English: Methotrexate Disodium 548.37mg Vial
Estonian: Metotreksaati Disodium 548.37mg Vial
English: Methotrexate Sodium 54.84mg Vial
Estonian: Metotreksaati Sodium 54.84mg Vial
English: Metotrexat Medac Methotrexate 50mg/Ml
Estonian: Metotrexat Medac Metotreksaati 50mg/Ml
English: Methotrexate Sodium 5.484mg Vial
Estonian: Metotreksaati Sodium 5.484mg Vial
English: Metotrexate Ebewe Methotrexate 10mg/Ml
Estonian: Metotrexate Ebewe Metotreksaati 10mg/Ml
English: Methotrexat Ebewe Methotrexate 10mg Tablet
Estonian: Methotrexat Ebewe Metotreksaati 10mg Tablet
English: Methotrexate Sodium 548.4mg Vial
Estonian: Metotreksaati Sodium 548.4mg Vial
English: Intravenous Use |
Estonian: Intraarteriaalne |
English: Metotreksat Ebewe Methotrexate 5mg Tablet
Estonian: Metotreksat Ebewe Metotreksaati 5mg Tablet
English: Methotrexat Ebewe Methotrexate 20mg/Ml
Estonian: Methotrexat Ebewe Metotreksaati 20mg/Ml
English: Metotrexato Mylan Methotrexate 25mg/Ml
Estonian: Metotrexato Mylan Metotreksaati 25mg/Ml
English: Метожект Pen Methotrexate 25mg/0.5ml
Estonian: Метожект Pen Metotreksaati 25mg/0.5ml
English: Methotrexate 100ml/Ml
Estonian: Metotreksaati 100ml/Ml
English: Methotrexate Orion Methotrexate 10mg Tablet
Estonian: Methotrexate Orion Metotreksaati 10mg Tablet
English: Methotrexate Cipla Methotrexate 2.5mg Tablet
Estonian: Methotrexate Cipla Metotreksaati 2.5mg Tablet
English: Methotrexate 2.5mg Tablet
Estonian: Metotreksaati 2.5mg Tablet
English: Metotrexato Cipla Methotrexate 2.5mg Tablet
Estonian: Metotrexato Cipla Metotreksaati 2.5mg Tablet
English: Methotrexat Ebewe Methotrexate 5mg Tablet
Estonian: Methotrexat Ebewe Metotreksaati 5mg Tablet
English: Methotrexate Disodium 54.83mg Vial
Estonian: Metotreksaati Disodium 54.83mg Vial
English: Methotrexat Ebewe Methotrexate 2.5mg Tablet
Estonian: Methotrexat Ebewe Metotreksaati 2.5mg Tablet
English: Methotrexat Ebewe Methotrexate 10mg/Ml
Estonian: Methotrexat Ebewe Metotreksaati 10mg/Ml
English: Methotrexate 100mg/Ml Solution For Injection Intramuscular Use | Intravenous Use | Subcutaneous Use
Estonian: 100mg/Ml kontsentraat | intravenoosne
English: Czech Republic Accord Healthcare Limited Methotrexat Accord Methotrexate 50mg/2ml
Estonian: Tšehhi Vabariik Accord Healthcare Limited Methotrexat Accord Metotreksaati 50mg/2ml
English: Methotrexate Teva Methotrexate Sodium 10mg Tablet
Estonian: Methotrexate Teva Metotreksaati Sodium Tablett
English: Czech Republic Accord Healthcare Limited Methotrexat Accord Methotrexate 500mg/20ml
Estonian: Tšehhi Vabariik Accord Healthcare Limited Methotrexat Accord Metotreksaati 500mg/20ml
English: Methotrexate 7.5mg Tablet
Estonian: Metotreksaati 7.5mg Tablet
English: Methotrexate Teva Methotrexate 26mg/Ml
Estonian: Methotrexate Teva Metotreksaati 26mg/Ml
English: Solution For Injection Intramuscular Use
Estonian: Süste-/infusioonilahus Intramuskulaarne | intravenoosne
English: Metotrexato Pfizer Methotrexate 25mg/Ml
Estonian: Methotrexate Pfizer Metotreksaati 25mg/Ml
English: Czech Republic Accord Healthcare Limited Methotrexat Accord Methotrexate 5000mg/50ml
Estonian: Tšehhi Vabariik Accord Healthcare Limited Methotrexat Accord Metotreksaati 5000mg/50ml
English: Czech Republic Accord Healthcare Limited Methotrexat Accord Methotrexate 1000mg/10ml
Estonian: Tšehhi Vabariik Accord Healthcare Limited Methotrexat Accord Metotreksaati 1000mg/10ml
English: Methotrexat ”ebew e”
Estonian: Methotrexat ”ebewe”
English: Intraarterial Use | Intramuscular Use | Intravenous Use
Estonian: Intraarteriaalne | intramuskulaarne | intravenoosne
English: Metotrexat Astron Methotrexate 25mg/0.5ml
Estonian: Metotrexat Astron Metotreksaati 25mg/0.5ml
English: Solution For Injection Intravenous Use
Estonian: Ravimvorm Manustamisviis intravenoosne
English: Czech Republic Accord Healthcare Limited Methotrexat Accord Methotrexate 1000mg/40ml
Estonian: Tšehhi Vabariik Accord Healthcare Limited Methotrexat Accord Metotreksaati 1000mg/40ml
English: Solution For Injection Intramuscular Use | Intrathecal Use | Intravenous Injection
Estonian: Süste-/infusioonilahus Intramuskulaarne | intratekaalne| intravenoosne
English: Solution For Injection Intraarterial Use | Intramuscular Use | Intravenous Use
Estonian: Süste-/infusioonilahus Intraarteriaalne | intramuskulaarne | intratekaalne| intravenoosne
English: Accord Healthcare Limited Metotrexát Accord Methotrexate 50mg/20ml
Estonian: Accord Healthcare Limited Metotrexát Accord Metotreksaati 50mg/20ml
English: Methotrexate Disodium 5483mg Vial
Estonian: Metotreksaati Disodium 5483mg Vial
English: Methotrexate 5mg Tablet
Estonian: Metotreksaati 5mg Tablet
English: Intravenous Use | Subcutaneous Use
Estonian: Biodim intravenoosne | subkutaanne
English: Denmark
Estonian: Holland
English: Metotreksat Cipla Methotrexate 2.5mg Tablet
Estonian: Metotreksat Cipla Metotreksaati 2.5mg Tablett
English: Methotrexate Teva Methotrexate 25mg/Ml
Estonian: Methotrexaat Teva Metotreksaati 25mg/Ml
English: Injection/Infusion
Estonian: Süste/infusioonilahuse kontsentraat
English: Metotressato Teva Methotrexate 25mg/Ml
Estonian: Metotressato Teva Metotreksaati 25mg/Ml
English: Annex I
Estonian: Ühendkuningrii k
English: Metotreksat Ebewe Methotrexate 100mg/Ml Concentrate For Solution For Infusion
Estonian: Metotreksaat 100mg/ml Infusioonilahuse kontsentraat
English: Methotrexate 10mg Tablet
Estonian: Metotreksaati 10mg Tablet
English: Intraarterial Use | Intramuscular Use | Intrathecal Use | Intravenous Use | Intraventricular Use
Estonian: Intraarteriaalne | intramuskulaarne | intratekaalne| intravenoosne | subkutaanne
English: Methotrexate 25mg Vial Solution For Injection Intramuscular Use | Intrathecal Use | Intravenous Use
Estonian: 500mg/5ml kontsentraat intramuskulaarne | intravenoosne
English: Accord Healthcare Limited Metotrexato Accord Methotrexate 5000mg/50ml
Estonian: Accord Healthcare Limited Metotrexato Accord Metotreksaati 5000mg/50ml
English: Intraarterial Use | Intramuscular Use | Intrathecal Use | Intratumoral Use | Intravenous Use
Estonian: Ravimvorm Manustamisviis intramuskulaarne | intratekaalne| intravenoosne
English: Accord Healthcare Limited Methotrexat Accord Methotrexate 5000mg/50ml
Estonian: Accord Healthcare Limited Methotrexat Accord Metotreksaati 5000mg/50ml
English: Accord Healthcare Limited Metotreksat Accord Methotrexate 5000mg/50ml
Estonian: Accord Healthcare Limited Metotreksat Accord Metotreksaati 5000mg/50ml
English: Accord Healthcare Limited Methotrexat Accord Methotrexate 50mg/2ml
Estonian: Accord Healthcare Limited Methotrexat Accord Metotreksaati 50mg/2ml
English: Accord Healthcare Limited Methotrexat Accord Methotrexate 1000mg/10ml
Estonian: Accord Healthcare Limited Methotrexat Accord Metotreksaati 1000mg/10ml
English: Accord Healthcare Limited Methotrexat Accord Methotrexate 500mg/5ml
Estonian: Accord Healthcare Limited Methotrexat Accord Metotreksaati 500mg/5ml
English: Netherlands Accord Healthcare Limited Methotrexaat Accord
Estonian: Accord Healthcare Limited Methotrexaat Accord
English: Accord Healthcare Limited Methotrexat Accord Methotrexate 1000mg/40ml
Estonian: Accord Healthcare Limited Methotrexat Accord Metotreksaati 1000mg/40ml
English: Accord Healthcare Limited Methotrexat Accord Methotrexate 500mg/20ml
Estonian: Accord Healthcare Limited Methotrexat Accord Metotreksaati 500mg/20ml
English: Accord Healthcare Limited Metotrexato Accord Methotrexate 1000mg/10ml
Estonian: Accord Healthcare Limited Metotrexato Accord Metotreksaati 1000mg/10ml
English: Accord Healthcare Limited Metotrexato Accord Methotrexate 500mg/5ml
Estonian: Accord Healthcare Limited Metotrexato Accord Metotreksaati 500mg/5ml
English: Accord Healthcare Limited Metotrexato Accord Methotrexate 50mg/2ml
Estonian: Accord Healthcare Limited Metotrexato Accord Metotreksaati 50mg/2ml
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for methotrexate containing medicinal products
Estonian: LISA I RIIKLIKU MÜÜGILOAGA RAVIMITE LOEND
English: Accord Healthcare Limited Metotrexato Accord Methotrexate 1000mg/40ml
Estonian: Accord Healthcare Limited Metotrexato Accord Metotreksaati 1000mg/40ml
English: Accord Healthcare Limited Metotrexat Accord Methotrexate 50mg/2ml
Estonian: Accord Healthcare Limited Metotrexat Accord Metotreksaati 50mg/2ml
English: Accord Healthcare Limited Metotrexat Accord Methotrexate 500mg/5ml
Estonian: Accord Healthcare Limited Metotrexat Accord Metotreksaati 500mg/5ml
English: Accord Healthcare Limited Metotreksat Accord Methotrexate 1000mg/10ml
Estonian: Accord Healthcare Limited Metotreksat Accord Metotreksaati 1000mg/10ml
English: Accord Healthcare Limited Metotrexat Accord Methotrexate 1000mg/10ml
Estonian: Accord Healthcare Limited Metotrexat Accord Metotreksaati 1000mg/10ml
English: Accord Healthcare Limited Metotrexato Accord Methotrexate 500mg/20ml
Estonian: Accord Healthcare Limited Metotrexato Accord Metotreksaati 500mg/20ml
English: Accord Healthcare Limited Metotrexat Accord Methotrexate 1000mg/40ml
Estonian: Accord Healthcare Limited Metotrexat Accord Metotreksaati 1000mg/40ml
English: Accord Healthcare Limited Metotreksat Accord Methotrexate 500mg/5ml
Estonian: Accord Healthcare Limited Metotreksat Accord Metotreksaati 500mg/5ml
English: Accord Healthcare Limited Metotreksat Accord Methotrexate 50mg/2ml
Estonian: Accord Healthcare Limited Metotreksat Accord Metotreksaati 50mg/2ml
English: Accord Healthcare Limited Metotrexat Accord Methotrexate 500mg/20ml
Estonian: Accord Healthcare Limited Metotrexat Accord Metotreksaati 500mg/20ml
English: Accord Healthcare Limited Metotreksat Accord Methotrexate 1000mg/40ml
Estonian: Accord Healthcare Limited Metotreksat Accord Metotreksaati 1000mg/40ml
English: Accord Healthcare Limited Metotreksat Accord Methotrexate 500mg/20ml
Estonian: Accord Healthcare Limited Metotreksat Accord Metotreksaati 500mg/20ml
English: Accord Healthcare Limited Metotrexát Accord Methotrexate 1000mg/40ml
Estonian: Accord Healthcare Limited Metotrexát Accord Metotreksaati 1000mg/40ml
English: Accord Healthcare Limited Metotrexát Accord Methotrexate 500mg/20ml
Estonian: Accord Healthcare Limited Metotrexát Accord Metotreksaati 500mg/20ml
English: These measures will help protect the environment.
Estonian: Need meetmed aitavad kaitsta keskkonda.
English: It will be the smallest quantity necessary to get the desired information.
Estonian: See on väikseim kogus, mis on vajalik soovitud teabe saamiseks.
English: Other sources of information
Estonian: Muud teabeallikad
English: UNIQUE IDENTIFIER - 2D BARCODE Not applicable.
Estonian: AINULAADNE IDENTIFIKAATOR - 2D-vöötkood Ei kohaldata.
English: The following information is intended for medical or healthcare professionals only:
Estonian: Järgmine teave on üksnes meditsiini- või tervishoiutöötajale:
English: An updated RMP should be submitted: • At the request of the European Medicines Agency;
Estonian: Ajakohastatud riskijuhtimiskava tuleb esitada: • Euroopa Ravimiameti nõudel;
English: Elderly patients aged 65 or older (32%) were evaluated in clinical studies; no safety issues were identified.
Estonian: 65-aastasi või vanemaid patsiente (32%) uuriti kliinilistes uuringutes; ohutusprobleeme ei tuvastatud.
English: Children and adolescents
Estonian: Lapsed ja noorukid
English: Uncommon (may affect up to 1 in 100 people):
Estonian: Aeg-ajalt (võib esineda kuni 1 inimesel 100st):
English: You will not have to store this medicine.
Estonian: Teil ei ole vaja seda ravimit säilitada.
English: For patient preparation, see section 4.4.
Estonian: Patsiendi ettevalmistus vt lõik 4.4.
English: No other interaction studies have been performed.
Estonian: Muid koostoime uuringuid ei ole tehtud.
English: However, in the case of an overdose, you will receive the appropriate treatment.
Estonian: Üleannustamise korral saate asjakohast ravi.
English: This medicine is not for use in children and adolescents under 18 years of age because it has not been studied in this age group.
Estonian: See ravim ei ole ette nähtud kasutamiseks lastel ja alla 18-aastastel noorukitel, sest ravimit ei ole selles vanuserühmas uuritud.
English: Date of first authorisation: 19 November 2014 Date of latest renewal:
Estonian: Müügiloa esmase väljastamise kuupäev: 19. november 2014 Müügiloa viimase uuendamise kuupäev:
English: % RCP = Counts (activity) in bottom half x 100
Estonian: % RCP = arv (aktiivsus) alumisel poolel x 100
English: Lymphoseek will only be used in special controlled areas.
Estonian: Lymphoseeki kasutatakse ainult spetsiaalselt kontrollitud kohtades.
English: Individual benefit/risk justification
Estonian: Kasu/riski individuaalne hindamine
English: Italia
Estonian: Itaalia
English: Total volume: ________mL
Estonian: Kogumaht: ________ml
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6 and 12.
Estonian: Seda ravimpreparaati ei tohi segada teiste ravimitega, välja arvatud nendega, mis on loetletud lõigus 6.6 ja
English: It is not a treatment for your illness.
Estonian: See ei ravi haigust.
English: Package Leaflet: Information for the Patient
Estonian: Pakendi infoleht: teave patsiendile
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA Not applicable.
Estonian: AINULAADNE IDENTIFIKAATOR - INIMLOETAVAD ANDMED Ei kohaldata.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Põhjendus Braille mitte lisamiseks
English: The following information is intended for the specialist only.
Estonian: Alljärgnev teave on üksnes spetsialistile.
English: Remove the strip from the chamber, let it dry and cut it in half.
Estonian: Riba võetakse kambrist välja, lastakse kuivada ja lõigatakse pooleks.
English: Injury, poisoning and procedural complications
Estonian: Vigastus, mürgistus ja protseduuri tüsistused
English: Three-sigma threshold value a Average of three 2-second counts or one 10-second count
Estonian: Kolme sigma künnisväärtus a Keskmiselt kolm 2-sekundilist või üks 10-sekundiline loendus
English: Other medicines and Lymphoseek
Estonian: Muud ravimid ja Lymphoseek
English: Adverse reactions observed during clinical studies are listed below by frequency category.
Estonian: Kliiniliste uuringute ajal täheldatud kõrvaltoimed on loetletud allpool sageduse kategooriate alustel.
English: The dose may be divided up into smaller amounts.
Estonian: Annuse võib jagada väiksemateks kogusteks.
English: Antonio Vivaldistraat 150 1083 HP Amsterdam Netherlands
Estonian: Antonio Vivaldistraat 150 1083 HP Amsterdam Holland
English: For each patient, the radiation exposure must be justifiable by the likely benefit.
Estonian: Iga patsiendi puhul peab kokkupuude kiirgusega olema õigustatud oodatava kasuga.
English: • frequent or urgent need to urinate
Estonian: • sage või pakiline urineerimisvajadus
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Estonian: Piiratud tingimustel väljastatav retseptiravim (vt I lisa: Ravimi omaduste kokkuvõte, lõik 4.2)
English: This means that the doctor can make more than one injection in the area around the tumour.
Estonian: See tähendab, et arst võib teha rohkem kui ühe süste kasvajat ümbritsevasse piirkonda.
English: Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Estonian: Iga naise puhul, kellel on menstruatsioon ära jäänud, tuleb eeldada rasedust, kuni ei ole tõendatud vastupidist.
English: The activity administered should in every case be as low as reasonably achievable to obtain the required diagnostic information.
Estonian: Manustatud aktiivsus peab igal üksikjuhul olema nii madal kui on vajaliku diagnostilise teabe saamiseks võimalik.
English: b Blood represents total body exposure segregated from independent measurements of other organs and tissues.
Estonian: b Veri esindab kogu keha ekspositsiooni eraldi teiste organite ja kudede sõltumatutest mõõtmistest.
English: Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines.
Estonian: Teatage oma nukleaarmeditsiini arstile, kui te võtate või olete hiljuti võtnud või kavatsete võtta mis tahes muid ravimeid.
English: Whatman Grade 1, 3MM, 31ET Chromatography strip
Estonian: Whatman nr 1, 3MM, 31ET kromatograafiapaber
English: Duration of the procedure Your nuclear medicine doctor will inform you about the usual duration of the procedure.
Estonian: Protseduuri kestus Teie nukleaarmeditsiini arst teavitab teid protseduuri tavalisest kestusest.
English: Frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (frequency cannot be estimated from the available data).
Estonian: Sageduse kategooriad on määratletud järgmiselt: väga sage (≥ 1/10), sage (≥ 1/100 kuni < 1/10), aeg-ajalt (≥ 1/1000 kuni < 1/100), harv (≥ 1/10 000 kuni < 1/1000), väga harv (< 1/10 000) ja teadmata (ei saa hinnata olemasolevate andmete alusel).
English: No data are available.
Estonian: Andmed puuduvad.
English: Pack sizes The glass vials are supplied in a carton containing 1 or 5 vials.
Estonian: Pakendi suurused Klaasviaalid tarnitakse karbis, mis sisaldab 1 või 5 viaali.
English: The nuclear medicine doctor uses a special camera to find Lymphoseek.
Estonian: Nukleaarmeditsiini arst kasutab Lymphoseeki leidmiseks spetsiaalset kaamerat.
English: Patient preparation
Estonian: Patsiendi ettevalmistus
English: The place depends on the type of tumour.
Estonian: Koht sõltub kasvaja liigist.
English: CAUTION RADIOACTIVE MATERIAL
Estonian: HOIATUS RADIOAKTIIVNE MATERJAL
English: The safety and efficacy of Lymphoseek in children and adolescents below the age of 18 years has not yet been established.
Estonian: Lymphoseeki ohutus ja efektiivsus lastel vanuses kuni 18 aastat ei ole tõestatud.
English: Although these are complementary to intraoperative gamma probing, such acquired images should not be considered a substitute for proficient and thorough intraoperative probing with a handheld gamma detection probe.
Estonian: Kuigi need täiendavad operatsiooniaegset gammasondeerimist, ei tohiks niimoodi saadud kujutisi pidada gammakiirguse avastamise pihusondiga tehtava asjatundliku ja põhjaliku operatsiooniaegse sondeerimise asendajaks.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Estonian: Kasutamata ravimpreparaat või jäätmematerjal tuleb hävitada vastavalt kohalikele nõuetele.
English: Driving and using machines
Estonian: Autojuhtimine ja masinatega töötamine
English: Their receipt, storage, use, transfer, and disposal are subject to the regulations and/or appropriate licenses of the competent official organisation.
Estonian: Preparaadi üleandmine, säilitamine, kasutamine, transport ja hävitamine peavad vastama pädevate asutuste eeskirjadele ja/või olema reguleeritud vastavate litsentsidega.
English: It is considered unlikely that Lymphoseek will affect your ability to drive or to use machines.
Estonian: Peetakse ebatõenäoliseks, et Lymphoseek mõjutaks teie autojuhtimise või masinate kasutamise võimet.
English: Vials are sealed under nitrogen; air or oxygen is harmful to the contents of the vial and therefore the vial should not be vented.
Estonian: Viaalid on suletud lämmastiku keskkonnas; õhk või hapnik on viaali sisule ohtlikud ja seetõttu ei tohi viaali ventileerida.
English: The radiolabelled product is a clear, colourless solution with no visible particles.
Estonian: Radioaktiivselt märgistatud ravim on ilma nähtavate osakesteta selge, värvitu lahus.
English: • Periodic safety update reports
Estonian: • Perioodilised ohutusaruanded
English: The radiolabelled solution is stable for 6 hours at a maximum of 25°C.
Estonian: Radioaktiivselt märgistatud lahus on stabiilne 6 tunni jooksul maksimaalsel temperatuuril 25 °C.
English: For each injection prepare a separate syringe.
Estonian: Igaks süsteks tuleb ette valmistada eraldi süstal.
English: Effective dose (E) (males, mSv/MBq)
Estonian: Efektiivne annus (E) (mehed, mSv/MBq)
English: For precautions with respect to environmental hazard, see section 6.6.
Estonian: Ettevaatusabinõud seoses keskkonnaohuga vt lõik 6.6.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE / MÜÜGILOA UUENDAMISE KUUPÄEV
English: • All lymphatic mapping agents use elements of the lymphatic system for distribution.
Estonian: • Kõik lümfisüsteemi kaardistusained kasutavad jaotumiseks lümfisüsteemi elemente.
English: This medicine is stored under the responsibility of the specialist in appropriate premises.
Estonian: Seda ravimit säilitatakse spetsialisti vastutusel selleks ettenähtud ruumides.
English: • irritation or pain where the injection is given (including the breast and skin)
Estonian: • ärritus või valu süstekohas (sealhulgas rind ja nahk)
English: Calibration time: ________Time/Date
Estonian: Kalibreerimisaeg: ________kellaaeg/kuupäev 6.
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Estonian: III LISA PAKENDI MÄRGISTUS JA INFOLEHT
English: External imaging and intraoperative evaluation may be performed using a gamma detection device.
Estonian: Välise visualiseerimise ja operatsiooniaegse hindamise võib läbi viia gammadetektoriga.
English: Other adverse reactions were uncommon, and of mild severity and short duration.
Estonian: Muid kõrvaltoimeid esines aeg-ajalt ning need olid mõõduka raskuse ja lühikese kestusega.
English: d. Calculate the percent radiochemical purity (% RCP) as follows:
Estonian: d. Radiokeemiline puhtus (%RCP) arvutatakse järgmise valemi järgi:
English: Only essential investigations should therefore be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and foetus.
Estonian: Raseduse ajal tohib seetõttu läbi viia ainult eluliselt vajalikke uuringuid, kui oodatav kasu on palju suurem võimalikust riskist emale ja lootele.
English: Marketing Authorisation Holder Norgine B.V.
Estonian: Müügiloa hoidja Norgine B.V.