FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacokinetics is nonlinear with the area under the plasma concentration curve (AUC) versus time curve increasing 3.8-fold as dose is doubled from 4.5 g to 9 g. The pharmacokinetics is not altered with repeat dosing.
Estonian: Farmakokineetilised parameetrid AUC vs ajakõver on mittelineaarsed, suurenedes 3,8 korda kui annus 4,5 grammilt kahekordistus 9 grammini.
English: Remove the cap from the first dosing cup by pressing down on the childresistant locking tab and turning the cap anticlockwise (to the left).
Estonian: Eemaldage kork esimeselt topsilt, surudes lastekindlat korki alla ja keerates seda vastupäeva (vasakule).
English: Sodium oxybate was non-mutagenic and non-clastogenic in in vitro and in vivo assays.
Estonian: In vivo ja in vitro katsetes osutus naatriumoksübaat mitte-mutageenseks ja mitte-klastogeenseks.
English: Cases of dependency have occurred after the illicit use of sodium oxybate.
Estonian: Pärast naatriumoksübaadi mittesihipärast (kuri)tarvitamist on esinenud sõltuvuse juhtumeid.
English: Drug interaction studies in healthy adults demonstrated no pharmacokinetic interactions between sodium oxybate and diclofenac.
Estonian: Ravimite koostoime uuringutes tervetel täiskasvanutel naatriumoksübaadiga ja diklofenakiga ei ilmnenud farmakokineetilisi koostoimeid.
English: TRIAL 2
Estonian: UURING 2
English: How to store Xyrem
Estonian: Kuidas Xyrem'i säilitada
English: Sodium oxybate is the sodium salt of GHB.
Estonian: Naatriumoksübaat on GHB naatriumisool.
English: For at least 6 hours after taking sodium oxybate, patients must not undertake activities requiring complete mental alertness or motor co-ordination, such as operating machinery or driving.
Estonian: Vähemalt 6 tundi pärast naatriumoksübaadi kasutamist ei tohi autot juhtida ega masinaid ning seadmeid käsitseda või sooritada kõrgendatud tähelepanu nõudvaid tegevusi.
English: Epworth Sleepiness Scale (ESS; range 0-24) Dose Group [g/d (n)] Baseline
Estonian: Tabel 2 Uuring 1 Epwort'i unisuse skaala (EUS) kokkuvõte Epworth'i unisuse skaala (EUS; vahemik 0...24)
English: The dose of sodium oxybate therefore does not require adjustment when given concomitantly with proton pump inhibitors.
Estonian: Seetõttu ei ole koos prootonpumba inhibiitoritega manustamisel naatriumoksübaadi annust vaja kohandada.
English: UCB Pharma Ltd.
Estonian: United Kingdom UCB Pharma Ltd.
English: If any of these apply to you, tell your doctor before you take Xyrem.
Estonian: Kui teil esineb mõni neist eelpool loetletud probleemidest, rääkige sellest enne Xyrem'i võtmist arstile.
English: Xyrem contains sodium
Estonian: Xyrem sisaldab naatriumi
English: The medicinal product should be used within 40 days after the first opening.
Estonian: Pärast pudeli esmakordset avamist kasutada ravim 40 päeva jooksul.
English: Drug interaction studies in healthy adults demonstrated no pharmacokinetic interactions between sodium oxybate and ibuprofen.
Estonian: Ravimite koostoime uuringutes tervetel täiskasvanutel naatriumoksübaadiga ja ibuprofeeniga ei ilmnenud farmakokineetilisi koostoimeid.
English: There is very limited experience with sodium oxybate in the elderly.
Estonian: Naatriumoksübaadi kasutamise kohta eakatel on piiratud kogemus.
English: The recommended starting dose is 4.5 g/day sodium oxybate divided into two equal doses of 2.25 g/dose.
Estonian: Soovitatud algannus on 4,5 g naatriumoksübaati/ööpäevas jagatuna kaheks võrdseks annuseks (st. 2,25 g/annus).
English: Increased sleepiness was observed after concomitant administration of sodium oxybate (2.25 g) and lorazepam (2 mg).
Estonian: Pärast naatriumoksübaadi (2,25 g) ja lorasepaami (2 mg) koosmanustamist täheldati suurenenud unisust.
English: Respiratory, thoracic and mediastinal disorders Common: dyspnoea, snoring, nasal congestion Not known: respiratory depression, sleep apnoea
Estonian: Respiratoorsed, rindkere ja mediastiinumi häired Sage: düspnoe, norskamine, ninakinnisus Teadmata: hingamisdepressioon, uneapnoe
English: The use of haemodialysis and other forms of extracorporeal medicinal product removal have not been studied in sodium oxybate overdose.
Estonian: Naatriumoksübaadi üleannuse korral ei ole uuritud ka hemodialüüsi ja teiste ekstrakorporaalsete eemaldusviiside kasulikkust.
English: The combined use of alcohol with sodium oxybate may result in potentiation of the central nervous system-depressant effects of sodium oxybate.
Estonian: Alkoholi ja naatriumoksübaadi kooskasutamine võib viia naatriumoksübaadi KNS pärssivate toimete potentseerumisele.
English: The starting dose should be halved in all patients with hepatic impairment, and response to dose increments monitored closely (see section 4.2).
Estonian: Kõigil maksafunktsioonihäiretega patsientidel peab Xyrem'i algannust poole võrra vähendama ja annuse suurendamist peab hoolikalt jälgima (vt lõik 4.2).
English: The discontinuation effects of sodium oxybate have not been systematically evaluated in controlled clinical trials.
Estonian: Kontrollitud kliinilistes uuringutes ei ole naatriumoksübaadi ärajätmisel tekkivaid toimeid süstemaatiliselt hinnatud.
English: Xyrem 500 mg/mL oral solution
Estonian: Xyrem 500 mg/ml suukaudne lahus Naatriumoksübaat
English: Blurred vision has been reported.
Estonian: Teatatud on ka nägemishäiretest.
English: The starting dose should be halved in all patients with hepatic impairment, and response to dose increments monitored closely (see section 4.4 and 5.2).
Estonian: Kõigil maksakahjustusega patsientidel on algannus poole võrra väiksem, ravivastust annuse suurendamisel tuleb väga tähelepanelikult jälgida (vt lõik 4.4).
English: Name and address of the manufacturer responsible for batch release
Estonian: A. RAVIMIPARTII KASUTAMISEKS VABASTAMISE EEST VASTUTAV TOOTJA Ravimipartii kasutamiseks vabastamise eest vastutava tootja nimi ja aadress UCB Pharma Ltd või
English: The oral solution is clear to slightly opalescent.
Estonian: Selge kuni kergelt opalestseeruv suukaudne lahus.
English: Median Change from Baseline
Estonian: Keskmine muutus algväärtusest
English: Drug interaction studies in healthy adults with sodium oxybate (single dose of 2.25 g) and lorazepam (single dose of 2 mg) and zolpidem tartrate (single dose of 5 mg) demonstrated no pharmacokinetic interactions.
Estonian: Ravimite koostoimete uuringutes tervetel täiskasvanud vabatahtlikel naatriumoksübaadiga (üksikannus 2,25 g) ja lorasepaamiga (üksikannus 2 mg) ja zolpideemtartraadiga (üksikannus 5 mg) ei ilmnenud farmakokineetilisi koostoimeid.
English: Xyrem 500 mg/mL oral solution Sodium oxybate
Estonian: RAVIMPREPARAADI NIMETUS Xyrem 500 mg/ml suukaudne lahus Natrii oxybas
English: Sleepwalking has been reported in patients treated in clinical trials with sodium oxybate.
Estonian: Kliinilistes uuringutes naatriumoksübaadiga ravitud patsientidel esines uneskõndimist.
English: Number of Subjects
Estonian: Osalejate arv
English: Drug interaction studies in healthy adults demonstrated no pharmacokinetic interactions between sodium oxybate (single dose of 2.25 g) and the antidepressants protriptyline hydrochloride (single dose of 10 mg) and duloxetine (60 mg at steady state).
Estonian: Ravimite koostoime uuringutes tervetel täiskasvanud vabatahtlikel naatriumoksübaadiga (üksikannus 2,25 g) ja antidepressantide protriptüliinvesinikkloriidiga (üksikannus 10 mg) ja duloksetiiniga (säilitusannus 60 mg) ei ilmnenud farmakokineetilisi koostoimeid.
English: Patients with succinic semialdehyde dehydrogenase deficiency.
Estonian: Suktsinaatdehüdrogenaasi defitsiidiga patsiendid.
English: Table 4 Summary of MWT in Trial 2
Estonian: Tabel 4 Uuringu 2 ärkveloleku testi säilimise (ÄTS) kokkuvõte
English: Changes in sleep patterns have been observed in breastfed infants from exposed mothers.
Estonian: Uuringud on näidanud, et rinnaga toidetavatel imikutel esineb unehäireid.
English: A drug interaction study in healthy adults demonstrated no pharmacokinetic interactions between sodium oxybate (single dose of 4.5 g) and modafinil (single dose of 200 mg).
Estonian: Ravimite koostoime uuringus tervetel täiskasvanud vabatahtlikel naatriumoksübaadiga (üksikannus 4,5 g) ja modafiniiliga (üksikannus 200 mg) ei ilmnenud farmakokineetilisi koostoimeid.
English: 246 MWT/Sleep Architecture/ Cataplexy/Naps/FOSQ
Estonian: ÄTS/Une struktuur/ Katapleksia/Uinak/UFT
English: When the bottle is delivered, there is a plastic covered foil seal which is on the top of the bottle, underneath the cap. Each pack contains one bottle, a press-in-bottle-adaptor (PIBA), a plastic measuring syringe and two dosing cups with child-resistant caps.
Estonian: Iga pakk sisaldab ühe pudeli, adapteri (PIBA), plastikust mõõtesüstla ja kaks lastekindlate korkidega annustamistopsi.
English: Seizures have been observed in patients treated with sodium oxybate.
Estonian: Naatriumoksübaadiga ravitud patsientidel on täheldatud krampide teket.
English: Sodium intake
Estonian: Infolehe sisukord
English: A drug interaction study in healthy adults with sodium oxybate (single dose of 2.25 g) and tramadol (single dose of 100 mg) demonstrated no pharmacokinetic/pharmacodynamic interaction.
Estonian: Ravimite koostoime uuringus tervetel täiskasvanud vabatahtlikel naatriumoksübaadiga (üksikannus 2,25 g) ja tramadooliga (üksikannus 100 mg) ei ilmnenud farmakokineetilisi/farmakodünaamilisi koostoimeid.
English: Common: sleep paralysis, somnolence, tremor, balance disorder, disturbance in attention, hypoesthesia, paraesthesia, sedation, dysgeusia Uncommon: myoclonus, amnesia, restless legs syndrome Not known: convulsion, loss of consciousness, dyskinesia
Estonian: Sage: une paralüüs, somnolentsus, treemor, tasakaalu häired, tähelepanu häired, hüpesteesia, paresteesia, sedatsioon, düsgeusia
English: The rate of adverse reactions has increased when sodium oxybate is co-administered with tricyclic antidepressants.
Estonian: Naatriumoksübaadi kasutamisel koos tritsükliliste antidepressantidega on kõrvaltoimete esinemissagedus suurenenud.
English: Sodium oxybate also has the potential to induce respiratory depression.
Estonian: Teadaolevalt pärsib naatriumoksübaat ka hingamist.
English: Renal and urinary disorders Common: enuresis nocturna, urinary incontinence
Estonian: Neerude ja kuseteede häired Sage: enuresis nocturna, uriinipidamatus Teadmata: pollakisuuria/uriinipakitsus, noktuuria
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE OUTER PACKAGING
Estonian: VÄLISPAKENDIL JA SISEPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED Karp ja pudel
English: Each mL of solution contains 500 mg of sodium oxybate.
Estonian: TOIMEAINE(TE) SISALDUS Iga ml lahust sisaldab 500 mg naatriumoksübaati.
English: PHARMACEUTICAL FORM AND CONTENTS
Estonian: RAVIMVORM JA PAKENDI SUURUS Suukaudne lahus
English: No reversal of the central depressant effects of sodium oxybate can be expected from flumazenil administration.
Estonian: Flumaseniili manustamise järgselt ei ole mõtet loota naatriumoksübaadi tsentraalse pärssiva toime pöörduvust.
English: There have been clinical observation(s) of coma and increased plasma GHB concentration after co-administration of sodium oxybate with topiramate.
Estonian: Naatriumoksübaadi ja topiramaadi samaaegsel manustamisel on täheldatud koomat ja gammahüdroksübutüraadi (GHB) sisalduse tõusu vereplasmas.
English: STATEMENT OF ACTIVE SUBSTANCE
Estonian: Algväärtus Lõppväärtus
English: Medicinal product subject to medical prescription
Estonian: RAVIMI VÄLJASTAMISTINGIMUSED Retseptiravim.
English: Renal impairment
Estonian: Sedatiivsed uinutid
English: What measures are being taken to ensure the safe and effective use of Pemetrexed Krka?
Estonian: Mis meetmed võetakse, et tagada ravimi Pemetrexed Krka ohutu ja efektiivne kasutamine?
English: Further information on Pemetrexed Krka can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Lisateave ravimi Pemetrexed Krka kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Pemetrexed Krka has been shown to be comparable to Alimta.
Estonian: Euroopa Ravimiamet järeldas, et vastavalt ELi nõuetele on tõendatud ravimi Pemetrexed Krka võrreldavus ravimiga Alimta.
English: As a result, the active form of pemetrexed slows down the formation of DNA and RNA and prevents the cells from dividing.
Estonian: Selle tulemusena aeglustab pemetrekseedi aktiivne vorm DNA ja RNA moodustumist ning takistab rakkude pooldumist.
English: It can also be used as a maintenance treatment in patients who have received platinum-based chemotherapy.
Estonian: Ravimit tohib kasutada ka säilitusraviks patsientidel, kes on saanud plaatinaravimitega keemiaravi.
English: What is Pemetrexed Krka and what is it used for?
Estonian: Mis on Pemetrexed Krka ja milleks seda kasutatakse?
English: The recommended dose of Permetrexed Krka is 500 mg per square metre of body surface area (calculated using the patient's height and weight).
Estonian: Pemetrexed Krka soovitatav annus on 500 mg kehapindala ruutmeetri kohta (arvutatakse patsiendi pikkuse ja kehakaalu järgi).
English: This slows down the division of cancer cells, while normal cells are only slightly affected.
Estonian: Selle tulemusena vähirakkude pooldumine aeglustub ja normaalsed rakud kahjustuvad vähe.
English: Because Pemetrexed Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Pemetrexed Krka on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: Pemetrexed is converted into its active form more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells.
Estonian: Pemetrekseed muundub aktiivseks vormiks kergemini vähirakkudes kui normaalsetes rakkudes, mistõttu ravimi aktiivse vormi sisaldus on vähirakkudes suurem ja toime pikem.
English: • malignant pleural mesothelioma (a cancer of the lining of the lungs that is usually caused by exposure to asbestos), where it is used together with cisplatin in patients who have not received chemotherapy before and whose cancer cannot be removed by surgery;
Estonian: • pleura maliigne mesotelioom (teatud kopsukelmevähk, mida tavaliselt põhjustab kokkupuude asbestiga), kasutades ravimit koos tsisplatiiniga patsientidel, kes ei ole varem keemiaravi saanud ja kelle vähkkasvajat ei saa kirurgiliselt eemaldada;
English: This means that Pemetrexed Krka contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Alimta.
Estonian: See tähendab, et Pemetrexed Krka sisaldab sama toimeainet ja toimib samamoodi nagu võrdlusravim Alimta, millel juba on ELis müügiluba.
English: For more information about using Pemetrexed Krka, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet ravimi Pemetrexed Krka kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pemetrexed Krka have been included in the summary of product characteristics and the package leaflet.
Estonian: Ravimi Pemetrexed Krka ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Alimta, and do not need to be repeated for Pemetrexed Krka.
Estonian: Võrdlusravimiga Alimta on juba tehtud toimeaine heakskiidetud kasutamisviisi(de) kasulikkuse ja riski uuringud ja neid ei ole vaja ravimiga Pemetrexed Krka korrata.
English: Therefore, the Agency's view was that, as for Alimta, the benefit of Pemetrexed Krka outweighs the identified risk and it can be authorised for use in the EU.
Estonian: Seetõttu on amet arvamusel, et nagu ka Alimta korral, ületab ravimi Pemetrexed Krka kasulikkus sellega kaasnevad riskid ja seda võib kasutada ELis.
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Krka.
Estonian: Kõrvalnähtude vähendamiseks peavad patsiendid võtma kortikosteroidi (teatud põletikuvastane ravim) ja foolhapet (teatud vitamiin) ning neile tuleb ravimiga Pemetrexed Krka toimuva ravi ajal süstida B12vitamiini.
English: Pemetrexed Krka (pemetrexed)
Estonian: Pemetrexed Krka (pemetrekseed)
English: Pemetrexed Krka is a cancer medicine used to treat two types of lung cancer:
Estonian: Pemetrexed Krka on vähiravim, mida kasutatakse kaht tüüpi kopsuvähi raviks:
English: In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes involved in producing nucleotides (the building blocks of DNA and RNA, the genetic material of cells).
Estonian: Pemetrekseed muundub organismis aine aktiivseks vormiks, mis blokeerib nukleotiidide (rakkude geenimaterjali DNA ja RNA komponendid) tekkes osalevate ensüümide toime.
English: • advanced non-small-cell lung cancer of the kind known as ‘non-squamous', where it is used either in combination with cisplatin in previously untreated patients or on its own in patients who have previously received cancer treatment.
Estonian: • kaugelearenenud mitteväikerakk-kopsuvähi muu kui lamerakuline vorm, kasutades ravimit koos tsisplatiiniga varem ravimata patsientidel või ainsa ravimina patsientidel, kes on varem saanud vähiravi.
English: Side effects reported with Pemetrexed Krka are carefully evaluated and any necessary action taken to protect patients.
Estonian: Ravimi Pemetrexed Krka kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Other information about Pemetrexed Krka
Estonian: Muu teave ravimi Pemetrexed Krka kohta
English: As for all medicines, data on the use of Pemetrexed Krka are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse ravimi Pemetrexed Krka kasutamise kohta pidevat järelevalvet.
English: As for every medicine, the company provided studies on the quality of Pemetrexed Krka.
Estonian: Nagu iga ravimi korral, esitas ettevõte ravimi Pemetrexed Krka kvaliteedi uuringud.
English: When Pemetrexed Krka is given with cisplatin, an antiemetic medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Estonian: Kui ravimit Pemetrexed Krka kasutatakse koos tsisplatiiniga, tuleb patsiendile enne või pärast tsisplatiiniannuse manustamist anda antiemeetikumi (oksendamise ennetamiseks) ja vedelikke (dehüdratsiooni ennetamiseks).
English: The medicine can only be obtained with a prescription and should only be given under the supervision of a doctor who is qualified in the use of chemotherapy.
Estonian: Seda tohib manustada üksnes keemiaravi kasutamises kogenud arsti järelevalve all.
English: An overview of Pemetrexed Krka and why it is authorised in the EU
Estonian: Ülevaade ravimist Pemetrexed Krka ja ELis müügiloa väljastamise põhjendus
English: The active substance in Pemetrexed Krka, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Estonian: Ravimi Pemetrexed Krka toimeaine pemetrekseed on antimetaboliitide rühma kuuluv tsütotoksiline ravim (ravim, mis hävitab poolduvaid rakke, näiteks vähirakke).
English: Pemetrexed Krka contains the active substance pemetrexed.
Estonian: Pemetrexed Krka sisaldab toimeainena pemetrekseedi.
English: There was no need for ‘bioequivalence' studies to investigate whether Pemetrexed Krka is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Estonian: Bioekvivalentsust, st kas Pemetrexed Krka imendub organismis samamoodi kui võrdlusravim, et saavutada toimeaine sarnane sisaldus veres, ei olnud vaja uurida.
English: Treatment should be delayed or stopped, or the dose reduced, in patients whose blood cell counts are low or who have certain other side effects.
Estonian: Kui patsiendi vererakkude sisaldus on liiga väike või esinevad teatud muud kõrvalnähud, tuleb ravi edasi lükata või katkestada või annust vähendada.
English: How does Pemetrexed Krka work?
Estonian: Kuidas Pemetrexed Krka toimib?
English: This is because Pemetrexed Krka is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Estonian: Seda ei olnud vaja, sest Pemetrexed Krka manustatakse veeniinfusioonina, mille abil satub toimeaine otse vereringesse.
English: How has Pemetrexed Krka been studied?
Estonian: Kuidas ravimit Pemetrexed Krka uuriti?
English: Pemetrexed Krka is available as a powder that is made up into a solution for infusion (drip) into a vein.
Estonian: Ravimit Pemetrexed Krka turustatakse infusioonilahuse (veeni tilgutatava lahuse) pulbrina.
English: What are the benefits and risks of Pemetrexed Krka?
Estonian: Milles seisneb ravimi Pemetrexed Krka kasulikkus ja mis riskid ravimiga kaasnevad?
English: Pemetrexed Krka received a marketing authorisation valid throughout the EU on 22 May 2018.
Estonian: Pemetrexed Krka (pemetrekseed) EMA/200355/2018
English: How is Permetrexed Krka used?
Estonian: Kuidas ravimit Pemetrexed Krka kasutatakse?
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 12 August 2010
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV 12. August 2010
English: Loc. Bellaria - 53018 Rosia - Sovicille (SI) Italy
Estonian: Loc. Bellaria - 53018 Rosia - Sovicille (SI) Itaalia
English: The use of a second dose should take into consideration the information provided in sections 4.4, 4.8 and 5.1.
Estonian: Teise annuse manustamisel tuleks arvestada informatsiooniga, mis on ära toodud lõikudes 4.4, 4.8 ja 5.1.
English: Other medicines and Focetria
Estonian: Muud ravimid ja Focetria
English: Like all medicines, Focetria can cause side effects, although not everybody gets them.
Estonian: Nagu kõik ravimid, võib ka Focetria põhjustada kõrvaltoimeid, kuigi kõigil neid ei teki.
English: A minor infection such as a cold should not be a problem, but your doctor or nurse should advise whether you could still be vaccinated with Focetria,
Estonian: Väiksem haigus nagu külmetus ei peaks olema probleemiks, aga teie arst või õde annab teile nõu, kas teid tohib Focetriaga vaktsineerida.
English: No data are available in children aged less than 6 months (see sections 4.8 and 5.1).
Estonian: Andmed puuduvad laste kohta vanuses alla 6 kuu (vt lõigud 4.8 ja 5.1).
English: None of the ingredient in the vaccine can cause flu.
Estonian: Mitte ükski vaktsiini koostisosa ei saa põhjustada grippi.
English: The multidose vial should preferably be used within 24 hours after first withdrawal.
Estonian: Mitmeannuseline viaal tuleks eelistatult ära kasutada 24 tunni jooksul pärast esimest väljatõmmet.
English: Anti-HA antibody
Estonian: Anti-HA antikeha
English: • Official batch release In accordance with Article 114 Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Estonian: • Ravimipartii ametlik kasutamiseks vabastamine Vastavalt direktiivi 2001/83/EÜ artiklile 114 toimub ravimipartii ametlik kasutamiseks vabastamine riikliku laboratooriumi või selleks eesmärgiks määratud laboratooriumi poolt.
English: Tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescriptionor have recently been given any other vaccine.
Estonian: Teatage oma arstile või meditsiiniõele, kui te kasutate või olete hiljuti kasutanud mis tahes muid ravimeid, kaasa arvatud ilma retseptita ostetud ravimeid, või kui teile on hiljuti manustatud mõnda muud vaktsiini.
English: • The correct way to prepare the vaccine prior to administration.
Estonian: • Vaktsiini õige ettevalmistamine enne manustamist.