FrancophonIA/ELRC3.0 huggingface dataset:
English: Estimated progression-free rates at 6 months were 98.4% for the everolimus arm and 83.4% for the placebo arm. At the final analysis, median time to angiomyolipoma progression was not reached.
Estonian: Oodatav 6 kuu progressioonivaba määr oli 98,4% everoliimuse ja 83,4% platseeborühmas.
English: Talk to your doctor if you wish to have children.
Estonian: Kui te soovite saada last, rääkige sellest oma arstiga.
English: Each Votubia 1 mg dispersible tablet contains 1 mg of everolimus.
Estonian: Iga Votubia 1 mg dispergeeruv tablett sisaldab 1 mg everoliimust.
English: Each Votubia 5 mg tablet contains 5 mg of everolimus.
Estonian: Iga Votubia 5 mg tablett sisaldab 5 mg everoliimust.
English: Table 7 EXIST-1 - SEGA response
Estonian: Tabel 7 EXIST-1 - subependümaalse hiidrakulise astrotsütoomi ravivastus
English: Metabolism and nutrition disorders Very common Decreased appetite, hypercholesterolaemia Common
Estonian: Söögiisu vähenemine, hüperkolesteroleemia
English: 30 x 1 dispersible tablets
Estonian: 30 x 1 dispergeeruvat tabletti
English: EXIST-1 (Study CRAD001M2301), a randomised, double-blind, multicentre phase III study of Votubia versus placebo, was conducted in patients with SEGA, irrespective of age.
Estonian: Votubiat platseeboga võrdlev randomiseeritud topeltpime mitmekeskuseline III faasi uuring EXIST-1 (CRAD001M2301) viidi läbi subependümaalse hiidrakulise astrotsütoomiga patsientidega sõltumata nende vanusest.
English: The primary efficacy endpoint was SEGA response rate based on independent central radiology review.
Estonian: Efektiivsuse esmaseks tulemusnäitajaks oli subependümaalse hiidrakulise astrotsütoomi ravivastuse määr hinnatuna sõltumatu juhtiva radioloogi poolt.
English: Diarrhoea
Estonian: Hemorraagia
English: Table 3 Adverse reactions reported in TSC studies
Estonian: Tabel 3 Tuberoosse skleroosi kompleksi uuringutes registreeritud kõrvaltoimed
English: Consider re-initiating Votubia at approximately 50% lower than the daily dose previously administered.
Estonian: Kaaluda Votubia-ravi ligikaudu 50% väiksema ööpäevase annusega kui eelnevalt manustatud.
English: Votubia 1 mg dispersible tablets are available in packs containing 30 dispersible tablets in perforated unit-dose blisters of 10 x 1 tablets each.
Estonian: Votubiat tugevusega 1 mg dispergeeruvaid tablette müüakse pakendites, mis sisaldavad 30 dispergeeruvat tabletti 10 x 1 kaupa perforeeritud üksikannuselises blisterpakendis.
English: 100 x 1 dispersible tablets
Estonian: 100 x 1 dispergeeruvat tabletti
English: If not administered within 30 minutes of preparation when using an oral syringe or 60 minutes when using a small glass, the suspension must be discarded and a new suspension must be prepared.
Estonian: Kui valmistatud suspensiooni ei manustata 30 minuti jooksul, kasutades suusüstalt või 60 minuti jooksul, kasutades väikest klaasi, tuleb see ära visata ning uus suspensioon valmistada.
English: Menorrhagia, ovarian cyst, vaginal haemorrhage Uncommon Menstruation delayed d
Estonian: Amenorröa d, ebaregulaarne menstruatsioonitsükkel d
English: Votubia 10 mg tablets everolimus
Estonian: Votubia 10 mg tabletid everolimusum
English: Dyslipidaemia (including hypercholesterolaemia and hypertriglyceridaemia) has been reported in patients taking Votubia.
Estonian: Votubia-ravi saavatel patsientidel on registreeritud düslipideemiat (sealhulgas hüperkolesteroleemiat ja hüpertriglütserideemiat).
English: 10 x 1 dispersible tablets
Estonian: 10 x 1 dispergeeruvat tabletti
English: Use scissors to open the blister along the dotted line.
Estonian: Avage blister lõigates kääridega piki punktiirjoont.
English: Each Votubia 2 mg dispersible tablet contains 2 mg of everolimus.
Estonian: Iga Votubia 2 mg dispergeeruv tablett sisaldab 2 mg everoliimust.
English: Votubia 5 mg tablets everolimus
Estonian: Votubia 5 mg tabletid everolimusum
English: AUC ↑2.7-fold (range 1.5-4.7) Cmax ↑1.8-fold (range 1.3-2.6)
Estonian: Suukaudne tsüklosporiin AUC ↑2,7-kordne (vahemik 1,5...4,7)
English: Therapeutic drug monitoring of everolimus blood concentrations, using a validated assay, is required for patients treated for SEGA.
Estonian: Subependümaalse hiidrakulise astrotsütoomi ravi saavatel patsientidel tuleb, kasutades selleks valideeritud analüüsimeetodit, jälgida everoliimuse terapeutilist kontsentratsiooni veres.
English: Each Votubia 3 mg dispersible tablet contains 3 mg of everolimus.
Estonian: Iga Votubia 3 mg dispergeeruv tablett sisaldab 3 mg everoliimust.
English: Votubia 1 mg dispersible tablets
Estonian: Votubia 1 mg dispergeeruvad tabletid
English: Each tablet contains 10 mg everolimus.
Estonian: Iga tablett sisaldab 10 mg everoliimust.
English: For patients who require use of corticosteroids for treatment of non-infectious pneumonitis, prophylaxis for pneumocystis jirovecii (carinii) pneumonia (PJP, PCP) may be considered.
Estonian: Pneumocystis jirovecii (carinii) põhjustatud pneumoonia (PJP, PCP) profülaktikat tuleb kaaluda patsientidel, kes vajavad mittenakkusliku pneumoniidi korral kortikosteroidravi.
English: Uncommon side effects (may affect up to 1 in 100 people) Rash of small fluid-filled blisters, appearing on reddened skin (signs of viral infection that can be potentially severe, also known as herpes zoster) Fever, chills, rapid breathing and heart rate, rash, and possibly confusion and disorientation (signs of serious infection, also known as sepsis)
Estonian: Aeg-ajalt esinevad kõrvaltoimed (võib tekkida kuni 1 inimesel 100st) Väikeste vesivillidega lööve, punetav nahk (viirusliku infektsiooni nähud, mis võivad olla tõsised, kutsutakse ka herpes zoster'iks)
English: Votubia 5 mg dispersible tablets
Estonian: Votubia 5 mg dispergeeeeruvad tabletid
English: If you do not use it within 60 minutes, throw it away and prepare a new suspension.
Estonian: Kui te ei manusta valmistatud suspensiooni 60 minuti jooksul, tuleb see ära visata ning uus suspensioon valmistada.
English: Table 6 EXIST-1 - SEGA response
Estonian: Tabel 6 EXIST-1 - subependümaalse hiidrakulise astrotsütoomi ravivastus
English: Each dispersible tablet contains 1 mg everolimus.
Estonian: Iga dispergeeruv tablett sisaldab 1 mg everoliimust.
English: Packs containing 30 x 1 or 100 x 1 dispersible tablets
Estonian: Pakendid sisaldavad 30 x 1 või 100 x 1 dispergeeruvat tabletti.
English: TSC with angiomyolipoma of the kidney in adults who do not require immediate surgery.
Estonian: Votubia tablette kasutatakse: tuberoosse skleroosi kompleksiga kaasneva neeru angiomüolipoomi raviks täiskasvanutel, kes ei vaja kohest opereerimist.
English: Each tablet contains 5 mg everolimus.
Estonian: Iga tablett sisaldab 5 mg everoliimust.
English: Exacerbation
Estonian: Süvenemine
English: White to slightly yellow, elongated tablets of approximately 10.1 x 4.1 mm, with a bevelled edge and no score, engraved with “LCL” on one side and “NVR” on the other.
Estonian: Valged kuni kergelt kollakad, piklikud kaldservaga ja ilma poolitusjooneta ligikaudu 10,1 x 4,1 mm tabletid, mille ühel küljel on graveering „LCL“ ja teisel küljel „NVR“.
English: Median time to SEGA progression based on central radiology review was not reached in either treatment arm. Progressions were only observed in the placebo arm (15.4%; p=0.0002).
Estonian: Progresseerumist täheldati ainult platseeborühmas (15,4%; p=0,0002).
English: Refill the glass with the same amount of water (approximately 30 ml), gently stir the remaining content and drink the whole amount to make sure that you get the full dose of Votubia tablets.
Estonian: Kui te võtate Votubiat tuberoosse skleroosi kompleksiga kaasneva subependümaalse hiidrakulise astrotsütoomi raviks ja kui te ei ole võimeline tablette alla neelama, võite te need lahustada klaasitäies vees: asetage vajalik arv tablette klaasitäie (umbes 30 ml) vee sisse, segage õrnalt klaasi sisu, kuni tablett (tabletid) lahustuvad (umbes 7 minutit) ja seejärel jooge vesi kohe ära, täitke klaas sama koguse (umbes 30 ml) veega, segage õrnalt klaasi sisu ja jooge kõik ära, et tagada kogu Votubia tablettide annuse manustamine.
English: If you do not use it within 30 minutes, throw it away and prepare a new suspension.
Estonian: Kui suspensiooni ei kasutata 30 minuti jooksul, tuleb see ära visata ja valmistada uus.
English: Therefore, absorption and subsequent elimination of everolimus may be influenced by products that affect CYP3A4 and/or PgP.
Estonian: Seetõttu võivad CYP3A4 ja / või PgP-le toimivad ravimid mõjutada everoliimuse imendumist ja järgnevat eliminatsiooni.
English: They are engraved with “5” on one side and “NVR” on the other.
Estonian: Tableti ühel küljel on graveering „5“ ja teisel küljel „NVR“.
English: If these side effects get severe please tell your doctor and/or pharmacist.
Estonian: Kui teil muutub ükski neist kõrvaltoimetest tõsiseks, teavitage otsekohe oma arsti või apteekrit.
English: Each dispersible tablet contains 2 mg everolimus.
Estonian: Iga dispergeeruv tablett sisaldab 2 mg everoliimust.
English: Votubia 1 mg dispersible tablets everolimus
Estonian: Votubia 1 mg dispergeeruvad tabletid everolimusum
English: Cases of pneumocystis jirovecii (carinii) pneumonia (PJP, PCP), some with fatal outcome, have been reported in patients who received everolimus.
Estonian: Everoliimust saanud patsientidel on teatatud pneumocystis jirovecii (carinii) põhjustatud pneumoonia (PJP, PCP) juhtudest, mõnel juhul surmlõppega.
English: Renal angiomyolipoma associated with tuberous sclerosis complex (TSC)
Estonian: Tuberoosse skleroosi kompleksiga kaasnev neeru angiomüolipoom
English: Includes (very common) rash; (common) rash erythematous, erythema and (uncommon) rash generalised, rash maculo-papular, rash macular d
Estonian: Sealhulgas (väga sage) lööve, (sage) erütematoosne lööve, erüteem ja (aeg-ajalt) generaliseerunud lööve, makulopapulaarne lööve, makulaarne lööve d
English: SEGA patients receiving concomitant potent CYP3A4 inducers may require an increased Votubia dose to achieve
Estonian: Subependümaalse hiidrakulise astrotsütoomiga patsiendid, kellele manustatakse samaaegselt tugevaid CYP3A4 indutseerijaid, võivad vajada suuremat Votubia annust, et saavutada tugevaid indutseerijaid mittemanustavate patsientidega samaväärne ravimi kontsentratsioon veres.
English: Votubia 2 mg dispersible tablets
Estonian: Votubia 2 mg dispergeeruvad tabletid
English: Each dispersible tablet contains 5 mg everolimus.
Estonian: Iga dispergeeruv tablett sisaldab 5 mg everoliimust.
English: Each dispersible tablet contains 3 mg everolimus.
Estonian: Iga dispergeeruv tablett sisaldab 3 mg everoliimust.
English: Votubia 3 mg dispersible tablets
Estonian: Votubia 3 mg dispergeeruvad tabletid
English: Votubia 3 mg and Votubia 5 mg dispersible tablets are available in packs containing 30 x 1 or 100 x1 dispersible tablets in perforated unit-dose blisters of 10 x 1 tablets each.
Estonian: Votubia dispergeeruvaid tablette tugevusega 3 mg ja 5 mg müüakse pakendites, mis sisaldavad 30 x 1 või 100 x 1 dispergeeruvat tabletti 10 x 1 kaupa perforeeritud üksikannuselises blisterpakendis.
English: Caregivers should try to avoid skin contact with the oral suspension.
Estonian: Hooldajad peaksid vältima suukaudse suspensiooni kokkupuutumist nahaga.
English: Votubia may be reinitiated at a daily dose approximately 50% lower than the dose previously administered depending on the individual clinical circumstances.
Estonian: Ravi Votubiaga võib sõltuvalt patsiendi kliinilisest seisundist uuesti alustada, kasutades varem manustatud annusest ligikaudu 50% väiksemat annust ööpäevas.
English: Each Votubia 5 mg dispersible tablet contains 5 mg of everolimus.
Estonian: Iga Votubia 5 mg dispergeeruv tablett sisaldab 5 mg everoliimust.
English: Votubia 3 mg dispersible tablets everolimus
Estonian: Votubia 3 mg dispergeeruvad tabletid everolimusum
English: Starting dose and target trough concentrations in TSC with refractory seizures The recommended starting dose for Votubia for the treatment of patients with seizures is shown in Table 1.
Estonian: Votubia soovitatav algannus hoogudega patsientide raviks on toodud tabelis 1.
English: White to slightly yellow, elongated tablets of approximately 12.1 x 4.9 mm, with a bevelled edge and no score, engraved with “5” on one side and “NVR” on the other.
Estonian: Valged kuni kergelt kollakad, piklikud kaldservaga ja ilma poolitusjooneta ligikaudu 12,1 x 4,9 mm tabletid, mille ühel küljel on graveering „5“ ja teisel küljel „NVR“.
English: Votubia 2 mg dispersible tablets everolimus
Estonian: Votubia 2 mg dispergeeruvad tabletid everolimusum
English: In this case, a dose of 2.5 mg daily must not be exceeded (see sections 4.4
Estonian: Sellisel juhul ei tohi ületada annust 2,5 mg päevas (vt lõigud 4.4 ja 5.2) Kui patsiendi maksa staatus (Child-Pugh klass) ravi ajal muutub, tuleb annust kohandada.
English: Votubia 5 mg dispersible tablets everolimus
Estonian: Votubia 5 mg dispergeeruvad tabletid everolimusum
English: What Votubia tablets looks like and contents of the pack Votubia 2.5 mg tablets are white to slightly yellowish, elongated tablets.
Estonian: Votubia 2,5 mg tabletid on valged kuni kergelt kollakad, piklikud tabletid.
English: Constipation, nausea, abdominal pain, flatulence, oral pain, gastritis Skin and subcutaneous tissue disorders Very common Rash c, acne
Estonian: Kõhukinnisus, iiveldus, kõhuvalu, kõhupuhitus, suuvalu, gastriit Naha ja nahaaluskoe kahjustused Väga sage
English: Votubia 5 mg tablets are available in packs containing 30 x 1 or 100 x 1 tablets in perforated unit-dose blisters of 10 x 1 tablets each.
Estonian: Votubia tablette tugevusega 5 mg müüakse pakendites, mis sisaldavad 30 x 1 või 100 x 1 tabletti, igas perforeeritud üksikannuselises blisterpakendis 10 x 1 tabletti.
English: Serious cases of haemorrhage, some with a fatal outcome, have been reported in patients treated with everolimus in the oncology setting.
Estonian: Onkoloogilisel näidustusel ravitud patsientide puhul on teatatud tõsistest hemorraagia juhtudest.
English: Votubia 10 mg tablets are available in packs containing 10 x 1, 30 x 1 or 100 x 1 tablets in perforated unit-dose blisters of 10 x 1 tablets each.
Estonian: Votubia tablette tugevusega 10 mg müüakse pakendites, mis sisaldavad 10 x 1, 30 x 1 või 100 x 1 tabletti, igas perforeeritud üksikannuselises blisterpakendis 10 x 1 tabletti.
English: Votubia 2 mg dispersible tablets are available in packs containing 10 x 1, 30 x 1 or 100 x 1 dispersible tablets in perforated unit-dose blisters of 10 x 1 tablets each.
Estonian: Votubiat tugevusega 2 mg dispergeeruvaid tablette müüakse pakendites, mis sisaldavad 10 x 1, 30 x 1 või 100 x 1 dispergeeruvat tabletti 10 x 1 kaupa perforeeritud üksikannuselises blisterpakendis.
English: Votubia 5 mg dispersible tablets are white to slightly yellowish, round, flat tablets with a bevelled edge and no score.
Estonian: Votubia 5 mg dispergeeruvad tabletid on valged kuni kergelt kollakad, ümarad, lamedad kaldservaga ja ilma poolitusjooneta tabletid.
English: Votubia 2.5 mg tablets are available in packs containing 10 x 1, 30 x 1 or 100 x 1 tablets in perforated unit-dose blisters of 10 x 1 tablets each.
Estonian: Votubia tablette tugevusega 2,5 mg müüakse pakendites, mis sisaldavad 10 x 1, 30 x 1 või 100 x 1 tabletti, igas perforeeritud üksikannuselises blisterpakendis 10 x 1 tabletti.
English: Cmax is dose-proportional between 5 and 10 mg. Everolimus is a substrate and moderate inhibitor of PgP.
Estonian: Everoliimus on PgP substraat ja mõõdukas inhibiitor.
English: White to slightly yellow, elongated tablets of approximately 15.1 x 6.0 mm, with a bevelled edge and no score, engraved with “UHE” on one side and “NVR” on the other.
Estonian: Valged kuni kergelt kollakad, piklikud kaldservaga ja ilma poolitusjooneta ligikaudu 15,1 x 6,0 mm tabletid, mille ühel küljel on graveering „UHE“ ja teisel küljel „NVR“.
English: They are engraved with “D5” on one side and “NVR” on the other.
Estonian: Tableti ühel küljel on graveering „D5“ ja teisel küljel „NVR“.
English: They are engraved with “D1” on one side and “NVR” on the other.
Estonian: Tableti ühel küljel on graveering „D1“ ja teisel küljel „NVR“.
English: For patients with renal angiomyolipoma associated with TSC:
Estonian: Tuberoosse skleroosi kompleksiga kaasneva neeru angiomüolipoomiga patsiendid:
English: Haemorrhage
Estonian: Nahalööve
English: They are engraved with “D3” on one side and “NVR” on the other.
Estonian: Tableti ühel küljel on graveering „D3“ ja teisel küljel „NVR“.
English: Votubia may be reinitiated at a daily dose approximately 50% lower than the dose previously administered.
Estonian: Ravi Votubiaga võib uuesti alustada, kasutades varem manustatud annusest ligikaudu 50% väiksemat annust ööpäevas.
English: Votubia 2 mg dispersible tablets are white to slightly yellowish, round, flat tablets with a bevelled edge and no score.
Estonian: Votubia 2 mg dispergeeruvad tabletid on valged kuni kergelt kollakad, ümarad, lamedad kaldservaga ja ilma poolitusjooneta tabletid.
English: Votubia 3 mg dispersible tablets are white to slightly yellowish, round, flat tablets with a bevelled edge and no score.
Estonian: Votubia 3 mg dispergeeruvad tabletid on valged kuni kergelt kollakad, ümarad, lamedad kaldservaga ja ilma poolitusjooneta tabletid.
English: Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC)
Estonian: Tuberoosse skleroosi kompleksiga kaasnev subependümaalne hiidrakuline astrotsütoom
English: They are engraved with “D2” on one side and “NVR” on the other.
Estonian: Tableti ühel küljel on graveering „D2“ ja teisel küljel „NVR“.
English: Monitoring of complete blood count is recommended prior to the start of Votubia therapy and periodically thereafter.
Estonian: Enne ravi alustamist Votubiaga ja korrapäraselt ravi ajal on soovitatav teostada täielik vereanalüüs.
English: General disorders and administration site conditions Very common Pyrexia, fatigue Investigations
Estonian: Üldised häired ja manustamiskoha reaktsioonid Väga sage
English: Push the plunger in slowly to release the full contents of the oral syringe.
Estonian: Süstla sisu välja laskmiseks lükake aeglaselt kolbi.
English: Steady-state pharmacokinetics
Estonian: Püsiseisundi farmakokineetika
English: Constipation
Estonian: Väsimustunne
English: White to slightly yellowish, round, flat tablets of approximately 12.1 mm in diameter, with a bevelled edge and no score, engraved with “D5” on one side and “NVR” on the other.
Estonian: Valged kuni kergelt kollakad, ümarad, lamedad kaldservaga ja ilma poolitusjooneta ligikaudu 12,1 mm läbimõõduga tabletid, mille ühel küljel on graveering „D5“ ja teisel küljel „NVR“.
English: White to slightly yellowish, round, flat tablets of approximately 9.1 mm in diameter, with a bevelled edge and no score, engraved with “D2” on one side and “NVR” on the other.
Estonian: Valged kuni kergelt kollakad, ümarad, lamedad kaldservaga ja ilma poolitusjooneta ligikaudu 9,1 mm läbimõõduga tabletid, mille ühel küljel on graveering „D2“ ja teisel küljel „NVR“.
English: - Keep this leaflet.
Estonian: Hoidke suusüstalt otsaga ülespoole.
English: Hold the oral syringe with the tip pointing upwards.
Estonian: Hoidke süstalt püstises asendis ots ülespoole.
English: They are engraved with “UHE” on one side and “NVR” on the other.
Estonian: Tableti ühel küljel on graveering „UHE“ ja teisel küljel „NVR“.
English: White to slightly yellowish, round, flat tablets of approximately 10.1 mm in diameter, with a bevelled edge and no score, engraved with “D3” on one side and “NVR” on the other.
Estonian: Valged kuni kergelt kollakad, ümarad, lamedad kaldservaga ja ilma poolitusjooneta ligikaudu 10,1 mm läbimõõduga tabletid, mille ühel küljel on graveering „D3“ ja teisel küljel „NVR“.
English: White to slightly yellowish, round, flat tablets of approximately 7.1 mm in diameter, with a bevelled edge and no score, engraved with “D1” on one side and “NVR” on the other.
Estonian: Valged kuni kergelt kollakad, ümarad, lamedad kaldservaga ja ilma poolitusjooneta ligikaudu 7,1 mm läbimõõduga tabletid, mille ühel küljel on graveering „D1“ ja teisel küljel „NVR“.
English: Children and adolescents Votubia can be used in children and adolescents SEGA associated with TSC.
Estonian: Votubiat tohib kasutada tuberoosse skleroosi kompleksiga kaasneva subependümaalse hiidrakulise astrotsütoomiga lastel ja noorukitel.
English: AUC ↑3.5-fold (range 2.2-6.3) Cmax ↑2.3-fold (range1.3-3.8)
Estonian: AUC ↑3,5-kordne (vahemik 2,2...6,3)
English: Plunger
Estonian: Silinder
English: Posology
Estonian: Suuhaavandid
English: Tell your doctor immediately if you experience these symptoms.
Estonian: Nendest sümptomitest tuleb teavitada oma arsti võimalikult kiiresti.
English: Stomatitis, including mouth ulcerations and oral mucositis, is the most commonly reported adverse reaction in patients treated with Votubia (see section 4.8).
Estonian: Votubiat võtvatel patsientidel on kõige sagedamini teatatud kõrvaltoime stomatiit, sealhulgas suuhaavandid ja suuõõne mukosiiti (vt lõik 4.8).
English: Median
Estonian: Vahemik
English: Starting dose and target trough concentrations in SEGA associated with TSC The recommended starting dose for Votubia for the treatment of patients with SEGA is 4.5 mg/m2.
Estonian: Algannus ja minimaalsed sihtkontsentratsioonid tuberoosse skleroosi kompleksiga kaasneva subependümaalse hiidrakulise astrotsütoomi korral Votubia soovituslik algannus subependümaalse hiidrakulise astrotsütoomi korral on 4,5 mg/m Farmakokineetilise simulatsiooni põhjal on suurem algannus, 7 mg/m2, soovitatav patsientidele vanuses alates 1 aasta kuni vähem kui 3 aastat (vt lõik 5.2).
English: Patients initially treated with placebo were allowed to cross over to everolimus at the time of SEGA progression and upon recognition that treatment with everolimus was superior to treatment with placebo.
Estonian: Subependümaalse hiidrakulise astrotsütoomi progresseerumisel ning olles kindlaks teinud, et everoliimus on platseebost efektiivsem, lubati algselt platseeboravi saanud patsiendid üle viia everoliimusravile.
English: It is essential to assess everolimus blood levels in cases of suspected overdose.
Estonian: Üleannustamise kahtluse korral on oluline määrata everoliimuse kontsentratsioon veres.
English: • This can help to reduce the effects of this illness.
Estonian: • See võib aidata selle haiguse mõjusid vähendada.
English: These signs are listed at the beginning of section 4.
Estonian: Need tunnused on loetletud lõigu 4 alguses.
English: • Low or high blood pressure
Estonian: • madal või kõrge vererõhk
English: Your healthcare professional will throw away any medicines that are no longer being used.
Estonian: Teie tervishoiuspetsialist viskab ära ravimid, mida enam ei kasutata.
English: This causes the symptoms of the illness.
Estonian: See põhjustab haiguse sümptomeid.
English: Primary mNIS+7b
Estonian: Esmane mNIS+7b
English: 3 weeks.
Estonian: 3 nädala järel.
English: Your doctor will tell you whether your condition allows you to drive vehicles and use machines safely.
Estonian: Arst ütleb teile, kas teie seisund võimaldab teil ohutult autot juhtida ja masinaid kasutada.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 August 2018
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV Müügiloa esmase väljastamise kuupäev: 27. august 2018
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1320/001
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/18/1320/001
English: Infusion-related reactions Infusion-related reactions are very common (may affect more than 1 in 10 people).
Estonian: Infusiooniga seotud reaktsioonid Infusiooniga seotud reaktsioonid on väga sagedad (võivad tekkida rohkem kui 1 inimesel 10-st).
English: Onpattro is used in adults only.
Estonian: Onpattrot kasutatakse ainult täiskasvanutel.
English: One additional patient had pre-existing anti-drug antibodies.
Estonian: Veel ühel patsiendil olid juba varem ravimivastased antikehad.
English: • Your doctor will work out how much Onpattro to give you - this will depend on your body weight.
Estonian: • Teie arst arvutab, kui palju Onpattrot teile manustada - see sõltub teie kehakaalust.