FrancophonIA/ELRC3.0 huggingface dataset:
English: MATERIALS, IF ANY {Invented name} should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Estonian: VÕI NENDE JÄÄTMETE, KUI NEID TEKIB, HÄVITAMISEL {Väljamõeldud nimetus} ei tohi sattuda veeteedesse, sest see võib olla ohtlik kaladele ja teistele veeorganismidele.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
Estonian: ERINÕUDED ETTEVAATUSABINÕUDE OSAS KASUTAMATA JÄÄNUD PREPARAADI
English: United Kingdom aniMedica GmbH Im Sudfeld
Estonian: Ühendkuningriik aniMedica GmbH Im Sudfeld
English: Hungary aniMedica GmgH, Im Südfeld 9
Estonian: Ungari aniMedica GmgH, Im Südfeld 9
English: 0.4% w/v Oral suspension Pigs
Estonian: Altrenogest 0.4% w/v Suukaudne suspensioon
English: Belgium Virbac S.A. 1ère avenue
Estonian: Ühendkuningriik Virbac S.A. 1ère avenue
English: To assess the risk to aquatic organisms from the use of veterinary medicinal products in gilts containing the synthetic steroidal hormone altrenogest, the MAHs conducted a Fish Full Life Cycle test to investigate and characterise the endocrine effects of this hormone, and also determined the PECsurfacewater from the use of the product as indicated in the summary of product characteristics (SPC), to establish if the concentrations expected in surface water would exceed the concentration known to cause a detrimental effect to aquatic populations of organisms in different representative EU scenarios (R1: Middle European land, R3: Middle European Mediterranean, and R4: Southern European Mediterranean).
Estonian: Eesmärk oli teha kindlaks, kas eeldatav sisaldus pinnavees ületab kontsentratsioonid, mis teadaolevalt on kahjulikud veeloomade populatsioonidele erinevate ELi representatiivsete stsenaariumide järgi (R1: Kesk-Euroopa, R3: Euroopa Vahemere piirkonna keskosa ja R4: Euroopa Vahemere piirkonna lõunaosa).
English: Poland Virbac S.A. 1ère avenue
Estonian: Tšehhi Vabariik Virbac S.A. 1ère avenue
English: Poland Intervet International B.V. Wim de Körverstraat B.V.
Estonian: Wim de Körverstraat B.V.
English: 40 pg/l was established.
Estonian: Selle alusel määrati kindlaks arvutuslik mittetoimiv sisaldus PNEC 40 pg/l.
English: Romania aniMedica GmbH Im Südfeld 9
Estonian: Rumeenia aniMedica GmbH Im Südfeld 9
English: Hungary Intervet International B.V. Wim de Körverstraat 35
Estonian: Madalmaad Intervet Nederland BV Wim de Korverstraat 35
English: France aniMedica GmbH Im Südfeld 9
Estonian: Prantsusmaa aniMedica GmbH Im Südfeld 9
English: The anaerobic transformation of altrenogest was investigated in pig manure incubated anaerobically according to the CVMP guideline on determining the fate of veterinary medicinal products in manure (EMA/CVMP/ERA/430327/2009)3.
Estonian: Uuriti altrenogesti anaeroobset lagunemist sigade sõnnikus, mida inkubeeriti anaeroobselt vastavalt veterinaarravimite komitee suunistele, mis käsitlevad veterinaarravimite lagunemist
English: Maximum PECsurfacewater concentrations were calculated using FOCUS STEP 4 modelling for all representative scenarios for different buffer zone (1 m, 3 m, 5 m, 10 m (Directive 91/676/EEC) These buffer zones are minimum distances to surface water which must be maintained when manure (or organic fertilizer) is spread onto cropland for the protection of waters against pollution caused by nitrates from agricultural sources which is implemented in national law in the EU Member States.
Estonian: FOCUS etapi 4 mudeliga arvutati maksimaalsed PECpinnavesikontsentratsioonid kõigi representatiivsete stsenaariumide eri puhvertsoonide jaoks (1 m, 3 m, 5 m, 10 m - direktiiv 91/676/EÜ).
English: MG/ML SOLUT ION BUVABLE POUR CHEVAUX
Estonian: REGUMATE EQUIN 2,2 MG/ML SOLUT ION BUVABLE POUR CHEVAUX
English: Poland AniMedica GmbH Im Südfeld 9
Estonian: AniMedica GmbH Im Südfeld 9
English: Germany Virbac 1ère Avenue 2065 m - LID 06516 Carros Cedex France
Estonian: Prantsusmaa Virbac 1ère Avenue 2065 m - LID 06516 Carros Cedex France
English: Belgium Ceva Santé Animale N.V. Metrologielaan 6
Estonian: Ceva Santé Animale N.V.
English: EU/1/07/416/002 Ecalta
Estonian: EU/1/07/416/002
English: 100 mg Powder for concentrate for solution for infusion
Estonian: Infusioonilahu se kontsentraadi pulber
English: MA (EU) number Name Strength Pharmaceutical Form
Estonian: Tugevus Ravimvorm Manustamistee Sisepakendi iseloomustus
English: EU Number
Estonian: EU protseduuri number
English: Packaging
Estonian: Intravenoosne
English: Zero days
Estonian: Null päeva.
English: This summary was last updated on 14.01.2010.
Estonian: Kokkuvõtte viimane uuendus: 14.01.2010.
English: This protects the pigs against the disease.
Estonian: See kaitseb sigu haiguse eest.
English: Sometimes, a slight increase in the rectal temperature might occur after vaccination.
Estonian: Mõnikord võib pärast vaktsineerimist rektaalne temperatuur mõnevõrra tõusta.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Estonian: Vaktsiinid õpetavad immuunsüsteemi (organismi loomulikke kaitsemehhanisme) kaitsma organismi haiguse eest.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Gripovac 3 to Merial on 14.01.2010.
Estonian: Euroopa Komisjon andis vaktsiini Gripovac 3 müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Merial 14.01.2010.
English: In case of accidental self-injection only a minor injection site reaction is expected.
Estonian: Juhusliku iseenesele süstimise korral on ootuspärane ainult kerge süstekoha reaktsioon.
English: The vaccine also contains ‘adjuvants' to stimulate a better response.
Estonian: Vaktsiin sisaldab parema immuunvastuse tekitamiseks ka adjuvante (toimet tugevdavaid aineid).
English: When a pig is given the vaccine, the immune system recognises the killed viruses as ‘foreign' and makes antibodies against them.
Estonian: Kui seale manustatakse vaktsiini, peab immuunsüsteem hävitatud viirusi võõrasteks ja tekitab nende vastu antikehi.
English: In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses.
Estonian: Kui immuunsüsteem puutub viirustega kokku hiljem uuesti, tekivad antikehad kiiremini.
English: Gripovac 3 is also used to vaccinate pregnant sows following their first immunisation by giving them one dose 14 days prior to farrowing in order that the sows milk contains enough antibodies to help protect the piglets against swine influenza for at least 33 days after birth.
Estonian: Vaktsiini Gripovac 3 kasutatakse ka tiinete emiste vaktsineerimiseks pärast esmast immuniseerimist, manustades neile ühekordse annuse 14 päeva enne poegimist, et emise piim sisaldaks piisavas koguses antikehi ning aitaks kaitsta põrsaid seagripi eest vähemalt 33 päeva jooksul pärast sündi.
English: A slight swelling may occur after vaccination at the site of injection in a small number of pigs but this goes down within 2 days.
Estonian: Mõnel seal võib pärast vaktsineerimist tekkida süstekohal kerge turse, mis kaob 2 ööpäeva jooksul.
English: Gripovac 3 is a vaccine.
Estonian: Gripovac 3 on vaktsiin.
English: Why has Gripovac 3 been approved?
Estonian: Miks Gripovac 3 heaks kiideti?
English: Gripovac 3 contains small amounts of a modified and then killed form of the pig's influenza virus that causes lesions and illness.
Estonian: Gripovac 3 sisaldab väikeses koguses kahjustusi ja haigust põhjustava sigade gripi viiruse modifitseeritud ja seejärel hävitatud vormi.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Gripovac 3 exceed the risks for the vaccination of pigs from the age of 56 days onwards inluding pregnant sows against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection and recommended that Gripovac 3 be given a marketing authorisation.
Estonian: Veterinaarravimite komitee otsustas, et vaktsiini Gripovac 3 kasulikkus on suurem kui sellega kaasnevad riskid vähemalt 56 päeva vanuste sigade, sealhulgas tiinete emiste vaktsineerimisel viiruse alatüüpide H1N1, H3N2 ja H1N2 põhjustatud seagripi eest, et vähendada haiguse kliinilisi nähte ja nakatumisjärgset viirusesisaldust kopsudes, ning soovitas anda vaktsiini Gripovac 3 müügiloa.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) GRIPOVAC 3 EPAR summary for the public
Estonian: GRIPOVAC 3 Kokkuvõte üldsusele
English: What is Gripovac 3?
Estonian: Mis on Gripovac 3?
English: Gripovac 3 is a vaccine that contains 3 different strains of swine influenza A virus which have been inactivated (killed).
Estonian: Gripovac 3 on vaktsiin, mis sisaldab sigade A-gripi viiruse 3 inaktiveeritud (hävitatud) tüve.
English: What is the risk associated with Gripovac 3?
Estonian: Mis riskid kaasnevad vaktsiiniga Gripovac 3?
English: Gripovac 3 is used to vaccinate pigs including pregnant sows over the age of 56 days against swine influenza in order to help them clinically but also to reduce the amount of virus present in the lungs.
Estonian: Vaktsiini Gripovac 3 kasutatakse sigade, sealhulgas üle 56 päeva vanuste tiinete emiste vaktsineerimiseks seagripi vastu, et aidata vähendada gripi kliinilisi nähte ning vähendada viiruse sisaldust kopsudes.
English: Other information about Gripovac 3:
Estonian: Muu teave vaktsiini Gripovac 3 kohta
English: Use of the Gripovac 3 in pigs reduces clinical signs and reduces the amount of virus in the lungs after infection caused by swine influenza A virus.
Estonian: Gripovac 3 kasutamine sigadel vähendab sigade A-gripi viiruse põhjustatud haiguse kliinilisi nähte ja viiruse sisaldust kopsudes.
English: Gripovac 3 is a suspension for injection.
Estonian: Gripovac 3 on süstesuspensioon.
English: What benefit has Gripovac 3 shown during the studies?
Estonian: Milles seisneb uuringute põhjal vaktsiini Gripovac 3 kasulikkus?
English: The effectiveness of Gripovac 3 has been studied in animals 56 days of age and older and in sows before and during pregnancy and these studies document that the vaccine protects against swine influenza.
Estonian: Vaktsiini Gripovac 3 efektiivsust uuriti vähemalt 56 päeva vanustel loomadel ning emistel enne tiinestumist ja tiinuse ajal.
English: What is Gripovac 3 used for?
Estonian: Milleks vaktsiini Gripovac 3 kasutatakse?
English: How does Gripovac 3 work?
Estonian: Kuidas vaktsiini Gripovac 3 uuriti?
English: Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Estonian: Manustamistee Sisepakendi iseloomustus Pakendi suurus
English: Rizmoic Rizmoic Rizmoic Rizmoic
Estonian: Ravimvorm
English: EU/1/18/1291/005 EU/1/18/1291/006
Estonian: Müügiloa nr Euroopa Liidus
English: ≥ 8 hours
Estonian: ≥ 8 tundi
English: Validation has not been successful, yet.
Estonian: Valideerimine ei ole veel õnnestunud.
English: The median time to event was nine days.
Estonian: Mediaanaeg tüsistuse tekkeni oli üheksa päeva.
English: Please note this medicine is mainly used in emergency situations, and the doctor will have decided that you needed it.
Estonian: Palun pange tähele, et seda ravimit kasutatakse eeskätt erakorralises meditsiiniabis ja teie arst on otsustanud, et te vajate seda.
English: The following information is intended for healthcare professionals only.
Estonian: Järgmine teave on ainult tervishoiutöötajatele:
English: Tell your doctor if you are taking, have recently taken, or might take, any other medicines.
Estonian: Teatage oma arstile, kui te võtate või olete hiljuti võtnud või kavatsete võtta mis tahes muid ravimeid.
English: The study should be based on an agreed protocol.
Estonian: Uuring peab tuginema kokkuleppelisel uuringuplaanil.
English: < 8 hours or unknown
Estonian: < 8 tundi või teadmata
English: In an updated interim analysis, data of 352 patients were evaluated.
Estonian: Uuendatud vaheanalüüsis hinnati 352 patsiendi andmeid.
English: The elimination halflife ranges from four to seven hours.
Estonian: Eritumise poolväärtusaeg on neli kuni seitse tundi.
English: Pharmacotherapeutic group: All other therapeutic products, antidotes.
Estonian: Farmakoterapeutiline rühm: kõik teised raviained, antidoodid.
English: Approximately half of the patients were male, and the mean age was 77.4 years.
Estonian: Ligikaudu pooled patsientidest olid meessoost ja keskmine iga oli 77,4 aastat.
English: • Calculated number of vials as given in table 1.
Estonian: • Vajalik arv viaale, nagu näidatud tabelis 1.
English: Read all of this leaflet carefully, because it contains important information for you.
Estonian: Lugege hoolikalt infolehte, sest siin on teile vajalikku teavet.
English: ATC code: V03AB38
Estonian: ATC-kood: V03AB38 Toimemehhanism
English: This medicine will be stored in the hospital, and these instructions are intended for hospital staff only.
Estonian: Seda ravimit hoitakse haiglas ja juhised on mõeldud ainuüksi haiglapersonalile.
English: The dissolution time for each vial is approximately three to five minutes.
Estonian: Iga viaali sisu lahustamiseks kulub ligikaudu kolm kuni viis minutit.
English: 1097 JB Amsterdam
Estonian: 1097 JB Amsterdam Holland
English: • Calculated number of vials (see section 4.2).
Estonian: • Vajalik arv viaale (vt lõik 4.2).
English: System organ class/ Preferred term
Estonian: Organsüsteemi klass / eelistermin
English: Frequency in bleeding patients
Estonian: Esinemissagedus verejooksuga patsientidel
English: C/ La Relba s/n
Estonian: C/ La Relba s/n Porrino
English: Haemostatic efficacy was good or excellent in 81.9% of 249 patients.
Estonian: Hemostaatiline efektiivsus oli hea või väga hea 81,9% 249 patsiendist.
English: Distribution The Vd for andexanet alfa is 5.3 ± 2.6 L, approximately equivalent to the blood volume.
Estonian: Jaotumine Alfaandeksaneedi Vd on 5,3 ± 2,6 l, ligikaudu võrdväärne vere mahuga.
English: Submission by 30 September
Estonian: Esitada 30. septembriks
English: DO NOT SHAKE the vials, as this can lead to foaming.
Estonian: ÄRGE LOKSUTAGE viaale, kuna see võib põhjustada vahu teket.
English: It is unlikely that Ondexxya will influence the effect of other medicines or that other medicines will influence Ondexxya.
Estonian: Ei ole tõenäoline, et Ondexxya mõjutab muude ravimite toimet või et muud ravimid mõjutavad Ondexxya toimet.
English: In case of mild or moderate infusion reactions, careful observation may be sufficient.
Estonian: Kerge või mõõduka infusioonireaktsiooni korral võib piisata hoolikast jälgimisest.
English: Frequency in healthy volunteers
Estonian: Esinemissagedus tervetel vabatahtlikel
English: Other medicines and Ondexxya
Estonian: Muud ravimid ja Ondexxya
English: Of 352 enrolled patients, 249 (70.7%) were included in the efficacy-analysis.
Estonian: Uuringusse kaasatud 352 patsiendist 249 (70,7%) kaasati efektiivsuse analüüsi.
English: FXa inhibitor
Estonian: FXa inhibiitor
English: These antibodies were generally low titre, and no clinical consequences were observed.
Estonian: Nende antikehade kontsentratsioon oli üldjuhul väike ja kliinilisi tagajärgi ei täheldatud.
English: Among the healthy subjects studied, women experienced more adverse reactions (mainly infusion-related reactions) than men.
Estonian: Tervete uuritavate seas esines naistel rohkem kõrvaltoimeid (peamiselt infusioonireaktsioonid) kui meestel.
English: Dosage recommendation is based upon data-modelling in healthy volunteers.
Estonian: Annusealased soovitused tuginevad tervete vabatahtlike andmete modelleerimisele.
English: Known allergic reaction to hamster proteins.
Estonian: Teadaolev allergiline reaktsioon hamstri valkude suhtes.
English: Contents of the pack and other information What Ondexxya contains
Estonian: Pakendi sisu ja muu teave Mida Ondexxya sisaldab
English: Although determination of anti-FXa-activity in emergency situations is increasingly recommended, no recommendation for adapted andexanet alfa dosage is available.
Estonian: Ehkki FXa-vastase toime kindlaksmääramine on erakorralises olukorras üha enam soovitatav, ei ole soovitusi alfaandeksaneedi kohandatud annuse kohta võimalik anda.
English: There is no information on the use of Ondexxya in children and adolescents.
Estonian: Ondexxya kasutamise kohta lastel ja noorukitel andmed puuduvad.
English: Duration of this effect in bleeding patients is not known.
Estonian: Selle toime kestus verejooksuga patsientidel ei ole teada.
English: What you need to know before you receive Ondexxya Do not use Ondexxya:
Estonian: Mida on vaja teada enne Ondexxya saamist Ärge kasutage Ondexxyat:
English: Data from bleeding patients are limited.
Estonian: Verejooksuga patsientidelt saadud andmed on piiratud.
English: Your doctor or nurse will give you this medicine by injection or infusion into a vein.
Estonian: Arst või meditsiiniõde manustab teile seda ravimit veenisisese süste või infusioonina.
English: Treatment-emergent, non-neutralizing antibodies to andexanet alfa were detected in approximately 10% (35/345).
Estonian: Ravist tingitud alfaandeksaneedivastaste mitteneutraliseerivate antikehade teket täheldati ligikaudu 10% juhtudest (35/345).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Estonian: Kui ravimit ei kasutata kohe, vastutab selle kasutuseelse säilitamisaja ja -tingimuste eest kasutaja.
English: Do not use this medicine after the expiry date which is stated on the vial and the carton after EXP.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud viaalil ja karbil pärast märget „EXP”.
English: Paediatric population: The safety and efficacy of andexanet alfa in children and adolescents have not been established.
Estonian: Lapsed: alfaandeksaneedi ohutus ja efektiivsus lastel ja noorukitel ei ole tõestatud.
English: Conclusions presented by the European Medicines Agency on: • Conditional marketing authorisation
Estonian: Euroopa Ravimiameti järeldused: • Tingimuslik müügiluba
English: The adverse reactions are classified by system organ class (SOC) and frequency, using the following convention: 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); or not known (cannot be estimated from available data).
Estonian: Kõrvaltoimed on rühmitatud organsüsteemi klasside järgi ning esinemissagedused 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); teadmata (ei saa hinnata olemasolevate andmete alusel).
English: Andexanet alfa has no or negligible influence on the ability to drive and use machines.
Estonian: Alfaandeksaneet ei mõjuta või mõjutab ebaoluliselt autojuhtimise ja masinate käsitsemise võimet.
English: Elderly patients (aged 65 years and over): No dose adjustment is required in elderly patients (see section 5.2).
Estonian: Erirühmad Eakad patsiendid (≥ 65-aastased): eakatel ei ole annuse kohandamine vajalik (vt lõik 5.2).
English: Based on its mechanism of action and on the characteristics of proteins, no carcinogenic or genotoxic effects are anticipated.
Estonian: Valkude toimemehhanismi ja omaduste põhjal ei ole kartsinogeenseid ega genotoksilisi toimeid oodata.
English: This medicine is unlikely to affect your ability to drive and use machines.
Estonian: See ravim ei mõjuta tõenäoliselt autojuhtimise ja masinate käsitsemise võimet.
English: 8 mg/min for 120 minutes (960 mg)
Estonian: 8 mg/min 120 minuti jooksul (960 mg)
English: All used syringes, needles, and vials, including any unused portion of reconstituted solution, should be disposed of in accordance with local requirements.
Estonian: Kõik kasutatud süstlad, nõelad ja viaalid, kaasaarvatud manustamiskõlblikuks muudetud lahuse kasutamata jäägid, tuleb hävitada vastavalt kohalikele nõuetele.
English: The interaction between andexanet alfa and TFPI has not been fully characterized.
Estonian: Alfaandeksaneedi ja TFPI vahelist koostoimet ei ole põhjalikult kirjeldatud.
English: Submission of the final CSR by 30 June
Estonian: Kliinilise uuringu lõplik aruanne esitada 30. juuniks
English: The time courses of anti-FXa activity before and after andexanet alfa administration are shown in Figure 1.
Estonian: FXa-vastase toime ajaline kulg enne ja pärast alfaandeksaneedi manustamist on toodud joonisel 1.
English: > 10 mg/ Unknown
Estonian: > 10 mg / teadmata
English: These elevations were maintained between several hours to a few days following administration, but no thrombotic events were reported.
Estonian: Need suurenenud näitajad püsisid mitu tundi kuni mitu päeva pärast manustamist, kuid tromboosidest/embooliatest ei teatatud.
English: In the ANNEXA-4 study, of the patients in the safety population completing 30-day follow up (N=351), 54 patients (15.4%) died.
Estonian: Uuringus ANNEXA-4 suri ohutuspopulatsiooni 30 päeva järelkontrollis osalenutest (N = 351) 54 patsienti (15,4%).
English: > 5 mg/ Unknown
Estonian: > 5 mg / teadmata
English: This medicine is for hospital use only.
Estonian: See ravim on ette nähtud ainult haiglas kasutamiseks.
English: The reconstituted solution is a clear, colourless, or slightly yellow solution.
Estonian: Manustamiskõlblikuks muudetud lahus on selge, värvitu või kergelt kollakas lahus.
English: • Large (60 mL or larger) sterile syringe.
Estonian: • Suur (vähemalt 60 ml) steriilne süstal.
English: 4 mg/min for 120 minutes (480 mg)
Estonian: 4 mg/min 120 minuti jooksul (480 mg)
English: mannitol, and polysorbate 80.
Estonian: mannitool ja polüsorbaat 80.
English: There were no blood clots in these healthy people.
Estonian: Neil tervetel inimestel verehüübeid ei tekkinud.
English: For moderate symptoms, consideration may be given to a brief interruption or slowing of the infusion with resumption of the infusion after symptoms subside.
Estonian: Mõõdukate sümptomite tekkimisel võib kaaluda infundeerimise lühiajalist katkestamist või aeglustamist ning jätkata infusiooniga pärast sümptomite taandumist.
English: Reduction in anti-FXa activity correlates with restoration of thrombin generation.
Estonian: FXa-vastase toime vähenemine korreleerub trombiini moodustumise taastumisega.
English: PK comparability with andexanet alfa in Ondexxya (Generation 2) has not yet been proven.
Estonian: Alfaandeksaneedi farmakokineetiline võrreldavus Ondexxyas (II põlvkond) ei ole veel tõestatud.
English: Reduction in anti-FXa activity
Estonian: FXa-vastase toime vähenemine
English: Vial (unopened) Two years stored at 2°C to 8°C.
Estonian: Viaal (avamata) Kaks aastat temperatuuril 2 °C...8 °C.
English: Use of andexanet alfa in conjunction with other supportive measures Andexanet alfa can be used in conjunction with standard haemostatic supportive measures, which should be considered as medically appropriate.
Estonian: Alfaandeksaneedi kasutamine koos muude toetusmeetmetega Alfaandeksaneeti võib kasutada koos standardsete meditsiiniliselt sobivate hemostaasi toetusmeetmetega.
English: For reconstituted solutions, chemical and physical in-use stability have been demonstrated for at least eight hours at 25°C.
Estonian: Manustamiskõlblikuks muudetud lahuse kasutusaegne keemilis-füüsikaline stabiilsus on tõestatud vähemalt kaheksa tunni jooksul temperatuuril 25 °C.
English: These markers were not measured in patients enrolled in the ANNEXA-4 study, but thromboembolic events have been observed (see section 5.1).
Estonian: Uuringusse ANNEXA-4 kaasatud patsientidel neid markereid ei hinnatud, kuid täheldati trombemboolia juhte (vt lõik 5.1).
English: Your doctor or nurse will work out the dose of this medicine that you need.
Estonian: Arst või meditsiiniõde arvutab välja teile vajaliku ravimiannuse.
English: The most frequently observed adverse reactions were mild or moderate infusion-related reactions (see table 4) comprising symptoms such as flushing, feeling hot, cough, dysgeusia, and dyspnoea occurring within a few minutes to a few hours of the infusion.
Estonian: Kõige sagedamini täheldatud kõrvaltoimed olid kerged või mõõdukad infusioonireaktsioonid (vt tabel 4), mis hõlmasid selliseid sümptomeid nagu õhetus, kuumatunne, köha, düsgeusia ja düspnoe, mis avaldusid mõne minuti kuni mõne tunni möödumisel infusioonist.