FrancophonIA/ELRC3.0 huggingface dataset:
English: Matever 1000 mg: The film-coated tablets are white, oblong, biconvex.
Estonian: Matever 1000 mg: Õhukese polümeerikattega tabletid on valged, piklikud, kaksikkumerad.
English: One tablet of Matever 250 mg contains 250 mg of levetiracetam.
Estonian: Üks Matever 250 mg tablett sisaldab 250 mg levetiratsetaami.
English: A 10.5 mg/kg (0.105 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
Estonian: Soovitatav on ravi esimesel päeval kasutada algannust 10,5 mg/kg (0,105 ml/kg) levetiratsetaami.
English: Each film-coated tablet contains 0.0025 mg sunset yellow FCF aluminum lake (E110).
Estonian: Üks õhukese polümeerikattega tablett sisaldab 0,0025 mg värvainet päikeseloojangukollane FCF alumiiniumlakk (E110).
English: Puh/Tel: +358 10 4261
Estonian: Suomi/Finland Orion Pharma Puh/Tel: +358 10 4261
English: Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more: General dose: between 1,000 mg and 3,000 mg each day.
Estonian: Annus täiskasvanutele ja noorukitele (12...17-aastased) kehakaaluga üle 50 kg Tavaline annus on vahemikus 1000 mg kuni 3000 mg iga päev.
English: 7 to 21 mg/kg (0.07 to 0.21 ml/kg) twice daily
Estonian: 7...21 mg/kg (0,07...0,21 ml/kg) kaks korda ööpäevas
English: 80 film-coated tablets
Estonian: 80 õhukese polümeerikattega tabletti
English: Each ml of solution for infusion contains 100 mg of levetiracetam.
Estonian: 1 ml infusioonilahust sisaldab 100 mg levetiratsetaami.
English: No adverse reactions on male or female fertility or reproduction performance were observed in rats at doses up to 1800 mg/kg/day (x 6 the MRHD on a mg/m2 or exposure basis) in parents and F1 generation.
Estonian: Ei ole ilmnenud kõrvaltoimeid isaste ja emaste rottide fertiilsusele või reproduktsioonile täiskasvanute ja F1 generatsioonis annuses kuni 1800 mg/kg ööpäevas (mis vastab 6-kordsele soovituslikule maksimaalsele ööpäevasele annusele inimesel mg/m kohta).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/711/014
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/11/711/030
English: Matever 750 mg: The film-coated tablets are pink, oblong, biconvex.
Estonian: Matever 750 mg: Õhukese polümeerikattega tabletid on roosad, piklikud, kaksikkumerad.
English: Matever 1000 mg film-coated tablets contain lactose.
Estonian: Matever 1000 mg õhukese polümeerikattega tabletid sisaldavad laktoosi.
English: • in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
Estonian: • partsiaalsete krambihoogude korral sekundaarse generaliseerumisega või ilma, epilepsiaga täiskasvanutele, noorukitele ja lastele alates 4 aasta vanusest.
English: Matever 100 mg/ml concentrate for solution for infusion levetiracetam
Estonian: Matever 100 mg/ml infusioonilahuse kontsentraat Levetiratsetaam
English: Matever 500 mg: The film-coated tablets are yellow, oblong, biconvex.
Estonian: Matever 500 mg: Õhukese polümeerikattega tabletid on kollased, piklikud, kaksikkumerad.
English: At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common.
Estonian: Kõrvaltoimed, nagu unisus, väsimus ja pearinglus on sagedamini ravi alguses või annuse suurendamisel.
English: The CLcr in ml/min/1.73 m may be estimated from serum creatinine (mg/dl) determination, for young adolescents and children using the following formula (Schwartz formula):
Estonian: Noorukite, laste ja imikute CLcr ml/min/1,73m võib määrata seerumi kreatiniinisisalduse järgi (mg/dl)
English: 3.5 to 7 mg/kg (0.035 to 0.07 ml/kg) twice daily
Estonian: 3,5...7 mg/kg (0,035...0,07 ml/kg) kaks korda ööpäevas
English: 7 to 14 mg/kg (0.07 to 0.14 ml/kg)once daily
Estonian: 7...14 mg/kg (0,07...0,14 ml/kg) üks kord ööpäevas
English: Monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.
Estonian: Monoteraapia partsiaalsete krampide puhul koos sekundaarse generaliseerumisega või ilma, esmaselt diagnoositud epilepsiaga patsientidel alates 16 aasta vanusest.
English: • Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more: General dose: between 1,000 mg and 3,000 mg each day.
Estonian: • Annus täiskasvanutele ja noorukitele (12...17-aastased) kehakaaluga üle 50 kg Tavaline igapäevane annus on 1000 mg kuni 3000 mg.
English: No special precautions for storage prior to reconstitution.
Estonian: See ravimpreparaat ei vaja säilitamise eritingimusi enne lahustamist.
English: Blood methotrexate and levetiracetam levels should be carefully monitored in patients treated concomitantly with the two medicinal products.
Estonian: Nende ravimite samaaegsel kasutamisel tuleb hoolikalt jälgida metotreksaadi ja levetiratsetaami sisaldust veres.
English: Matever 1000 mg film-coated tablets levetiracetam2.
Estonian: Matever 1000 mg õhukese polümeerikattega tabletid Levetiratsetaam
English: 200 mg twice daily
Estonian: 200 mg kaks korda päevas
English: 450 mg twice daily
Estonian: 450 mg kaks korda päevas
English: 5 to 15 mg/kg (0.05 to 0.15 ml/kg) twice daily
Estonian: 5...15 mg/kg (0,05...0,15 ml/kg) kaks korda ööpäevas
English: 3.5 to 10.5 mg/kg (0.035 to 0.105 ml/kg) twice daily
Estonian: 3,5...10,5 mg/kg (0,035...0,105 ml/kg) kaks korda ööpäevas
English: 600 mg twice daily
Estonian: 600 mg kaks korda päevas
English: 150 mg twice daily
Estonian: 150 mg kaks korda päevas
English: Warnings and precautions Talk to your doctor before taking Matever
Estonian: Enne Matever kasutamist rääkige oma arstiga:
English: Matever 750 mg film-coated tablets levetiracetam2.
Estonian: Matever 750 mg õhukese polümeerikattega tabletid Levetiratsetaam
English: 10 to 20 mg/kg (0.10 to 0.20 ml/kg) once daily
Estonian: 10...20 mg/kg (0,10 to 0,20 ml/kg) üks kord ööpäevas
English: • in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy.
Estonian: • partsiaalsete krambihoogude korral sekundaarse generaliseerumisega või ilma, epilepsiaga täiskasvanutele, noorukitele, lastele ja imikutele alates 1 kuu vanusest
English: Orion Pharma A/S Tlf: +45 49 12 66 00
Estonian: Tlf: +45 49 12 66 00
English: 7 to 14 mg/kg (0.07 to 0.14 ml/kg) twice daily
Estonian: 7...14 mg/kg (0,07...0,14 ml/kg) kaks korda ööpäevas
English: See the package leaflet for further information.
Estonian: Lisainformatsiooni vt pakendi infolehest.
English: Dosing adjustment for infants, children and adolescents patients weighing less than 50 kg with impaired renal function
Estonian: Annuse kohaldamine neerukahjustusega imikutel, lastel ja noorukitel kehakaaluga alla 50 kg: Grupp
English: In vitro studies show that levetiracetam affects intraneuronal Ca levels by partial inhibition of N-type
Estonian: In vitro uuringud näitavad , et levetiratsetaam mõjutab intraneuronaalset Ca ioonide sisaldust pärssides osaliselt N-tüüpi Ca-kanaleid ja vähendades Ca vabanemist rakusisestest depoodest.
English: • 750 mg: 20, 30, 50, 60, 80, 100, 120 and multipack of 200 (2 packs of 100) film-coated tablets.
Estonian: • 750 mg: 20, 30, 50, 60, 80, 100, 120 ja hulgipakend sisaldab 200 (2 pakendit, mis sisaldavad 100) õhukese polümeerikattega tabletti.
English: An oral solution is the preferred formulation for use in this population.
Estonian: Selles vanuserühmas eelistada suukaudset lahust.
English: 10 to 30 mg/kg (0.10 to 0.30 ml/kg) twice daily
Estonian: 10...30 mg/kg (0,10...0,30 ml/kg) kaks korda ööpäevas
English: You can switch from the film-coated tablets or from the oral solution to the intravenous formulation or reverse directly without dose adaptation.
Estonian: Üleminek suukaudselt manustamiselt intravenoossele või vastupidi on võimalik läbi viia kohe, ilma tiitrimata.
English: primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
Estonian: müoklooniliste krampide (lühiajalised šokitaolised lihaste või lihasrühmade tõmblused) raviks noorukiea müokloonilise epilepsiaga täiskasvanutel ja noorukitel alates 12 aasta vanusest primaarselt generaliseerunud toonilis-klooniliste krampide (rasked krambihood, millega kaasneb teadvusekaotus) ravis idiopaatilise generaliseerunud epilepsiaga täiskasvanutel ja noorukitel alates 12 aasta vanusest (epilepsia vorm, mille tekkepõhjust peetakse geneetiliseks).
English: Matever 750 mg film-coated tablets
Estonian: Matever, 750 mg, õhukese polümeerikattega tabletid
English: The NOAEL was < 200 mg/kg/day for the dams and 200 mg/kg/day for the fetuses (equal to the MRHD on a mg/m basis).
Estonian: NOAEL (No Observed Adverse Effect Level) oli emasloomadel <200 mg/kg ööpäevas ja loodetel 200 mg/kg ööpäevas (mis vastab soovituslikule maksimaalsele päevasele annusele inimesel mg/m kohta).
English: Adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy:
Estonian: Täiendravi partsiaalsete krampide puhul koos sekundaarse generaliseerumisega või ilma, epilepsiaga täiskasvanutel, noorukitel ja lastel alates 4. eluaastast:
English: 5 to 10 mg/kg (0.05 to 0.10 ml/kg) twice daily
Estonian: 5...10 mg/kg (0,05...0,10 ml/kg) kaks korda ööpäevas
English: • 250 mg: 20, 30, 50, 60, 100 and multipack of 200 (2 packs of 100) film-coated tablets.
Estonian: • 250 mg: 20, 30, 50, 60, 100 ja hulgipakend sisaldab 200 (2 pakendit, mis sisaldavad 100) õhukese polümeerikattega tabletti.
English: Matever 250 mg film-coated tablets levetiracetam2.
Estonian: Matever 250 mg õhukese polümeerikattega tabletid Levetiratsetaam
English: Matever 500 mg film-coated tablets levetiracetam2.
Estonian: Matever 500 mg õhukese polümeerikattega tabletid Levetiratsetaam
English: • 500 mg: 10, 20, 30, 50, 60, 100, 120 and multipack of 200 (2 packs of 100) film-coated tablets.
Estonian: • 500 mg: 10, 20, 30, 50, 60, 100, 120 ja hulgipakend sisaldab 200 (2 pakendit, mis sisaldavad 100) õhukese polümeerikattega tabletti.
English: Neonatal and juvenile animal studies in rats and dogs demonstrated that there were no adverse reactions seen in any of the standard developmental or maturation endpoints at doses up to 1800 mg/kg/day (x 6 - 17 the MRHD on a mg/m basis).
Estonian: Neonataalsete ja juveniilsete katseloomadega (rotid, koerad) läbiviidud uuringud annuste puhul kuni 1800 mg/kg ööpäevas (mis on 6…17-kordne soovituslik maksimaalne ööpäevane annus inimesel mg/m kohta) näitasid, et kōrvalekaldeid katseloomade arengu ja küpsuse tulemusnäitajates ei tekkinud.
English: Propylene glycol (E1520) Indigo carmine aluminum lake (E132) Sunset yellow FCF aluminum lake (E110)
Estonian: Propüleenglükool (E1520) Indigokarmiin alumiiniumlakk (E132) Päikeseloojangukollane FCF alumiiniumlakk (E110) Kinoliinkollane alumiiniumlakk (E104)
English: 10 to 20 mg/kg (0.10 to 0.20 ml/kg) twice daily
Estonian: 10...20 mg/kg (0,10...0,20 ml/kg) kaks korda ööpäevas
English: In patients aged 1 month to less than 4 years, a total of 190 patients have been treated with levetiracetam in placebo-controlled and open label extension studies.
Estonian: Platseebo-kontrollitud ja avatud jätku-uuringus raviti levetiratsetaamiga 190 last, vanuses 1 kuu…4aastat; neist 60 patsiendile anti levetiratsetaami platseebokontrolliga uuringus.
English: Nasopharyngit is
Estonian: Neerukahjustus
English: Matever 100 mg/ml concentrate for solution for infusion
Estonian: Matever, 100 mg/ml infusioonilahuse kontsentraat
English: Matever 250 mg, 750 mg tablets contain Sunset Yellow FCF (E110) Sunset Yellow FCF (E110) colouring agent may cause allergic reactions.
Estonian: Matever 250 mg, 750 mg tabletid sisaldavad värvainet päikeseloojangukollane FCF (E110).
English: Matever 1000 mg film-coated tablets
Estonian: Matever, 1000 mg, õhukese polümeerikattega tabletid
English: • in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
Estonian: • müoklooniliste krambihoogude korral täiskasvanutele ja noorukitele alates 12 aasta vanusest,
English: Matever contains sodium
Estonian: Matever sisaldab naatriumi.
English: • 1000 mg: 10, 20, 30, 50, 60, 100 and multipack of 200 (2 packs of 100) film-coated tablets.
Estonian: • 1000 mg: 10, 20, 30, 50, 60, 100 ja hulgipakend sisaldab 200 (2 pakendit, mis mõlemad sisaldavad 100) õhukese polümeerikattega tabletti.
English: Coating agent (yellow) consisting of: Hydroxypropylcellulose (E463) Hypromellose (E464) Propylene glycol (E1520) Quinoline yellow aluminium lake (E104) Sorbic acid (E200)
Estonian: Hüdroksüpropüültselluloos (E463) Hüpromelloos (E464) Propüleenglükool (E1520) Kinoliinkollane alumiiniumlakk (E104)
English: Add-on therapy for infants aged from 1 month to less than 6 months
Estonian: Täiendav ravi imikutele vanuses 1 kuu kuni 6 kuud Imikutele on saadaval suukaudne lahus.
English: Dosing adjustment for children and adolescents patients weighing less than 50 kg with impaired renal function
Estonian: Annuse kohaldamine neerukahjustusega lastel ja noorukitel kehakaaluga alla 50 kg: Rühm
English: Core
Estonian: Köha
English: • Dose in infants (1 month to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:
Estonian: • Annus imikutele (vanus 1 kuu kuni 23 kuud), lastele (2…11-aastased) ja noorukitele (12...17-aastased) kehakaaluga alla 50 kg Arst peab välja kirjutama vanusele, kehakaalule ja annusele kõige sobivama ravimi Matever ravimvormi.
English: 15 minutes Twice daily 1000 mg/day
Estonian: 1000 mg/ ööpäevas
English: Matever 500 mg film-coated tablets
Estonian: Matever, 500 mg, õhukese polümeerikattega tabletid
English: Box of 10, 20, 30, 50, 60, 100 multipack containing 200 (2 x 100) [with Blue Box]
Estonian: Karp N10, N20, N30, N50, N60, N100 hulgipakend sisaldab 200 (2 x 100) [BLUE BOX'IGA]
English: Matever 250 mg film-coated tablets
Estonian: Matever, 250 mg, õhukese polümeerikattega tabletid
English: Matever 1000 mg
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Matever 1000 mg
English: The recommended dose must be diluted in at least 100 ml of a compatible diluent and infused over 15 minutes.
Estonian: Soovitatud annus lahustatakse vähemalt 100 ml sobiva lahustiga ja infundeeritakse 15 minuti jooksul.. Arstide ja meditsiiniõdede jaoks on detailsem manustamisjuhis lõigus 6.
English: Infants 6 to 23 months, children and adolescents weighing less than 50 kg
Estonian: Annus ja sagedus 1…6-kuused imikud 6…23-kuused imikud, lapsed ja noorukid kehakaaluga kuni 50 kg
English: Box of 10, 20, 30, 50, 60, 100, 120 multipack containing 200 (2 x 100) [with Blue Box]
Estonian: Karp N10, N20, N30, N50, N60, N100, N120 Hulgipakend sisaldab N200 (2 x 100) [BLUE BOX'IGA]
English: Aluminium/PVC/PE/PVDC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 100, 120 and multipack containing 200 (2 packs of 100) film-coated tablets.
Estonian: Matever, 500 mg, õhukese polümeerikattega tabletid Alumiinium/PVC/PE/PVDC blistrid pappkarbis, mis sisaldavad 10, 20, 30, 50, 60, 100, 120 ja 200 (2 pakendist koosnev hulgipakend, milles mõlemas 100 tabletti) õhukese polümeerikattega tabletti.
English: Aluminium/PVC/PE/PVDC blisters placed into cardboard boxes containing 20, 30, 50, 60, 80, 100, 120 and multipack containing 200 (2 packs of 100) film-coated tablets.
Estonian: Matever, 750 mg, õhukese polümeerikattega tabletid Alumiinium/PVC/PE/PVDC blistrid pappkarbis, mis sisaldavad 20, 30, 50, 60, 80, 100, 120 ja 200 (2 pakendist koosnev hulgipakend, milles mõlemas 100 tabletti) õhukese polümeerikattega tabletti.
English: 15 minutes Twice daily 500 mg/day
Estonian: 15 minutit Kaks korda ööpäevas
English: Box of 20, 30, 50, 60, 80, 100, 120 multipack containing 200 (2 x 100) [with Blue Box]
Estonian: Karp N20, N30, N50, N60, N80, N100, N120 hulgipakend sisaldab N200 (2 x 100) [BLUE BOX'IGA]
English: With continued long-term treatment, 8.6 % of the patients were seizurefree for at least 6 months and 7.8 % were seizure-free for at least 1 year.35 infants aged less than 1 year with partial onset seizures have been exposed in placebo-control clinical studies of which only 13 were aged < 6 months.
Estonian: Platseebokontrolliga kliinilistes uuringutes osales 35 alla 1-aastast partsiaalsete krampidega imikut, kellest 13 olid alla 6-kuu vanused.
English: 15 minutes Twice daily 3000 mg/day
Estonian: 3000 mg/ ööpäevas
English: Matever 250 mg: The film-coated tablets are blue, oblong, biconvex.
Estonian: Kuidas Matever välja näeb ja pakendi sisu Matever 250 mg: Õhukese polümeerikattega tabletid on sinised, piklikud, kaksikkumerad.
English: Box of 20, 30, 50, 60, 100 multipack containing 200 (2 x 100) [with Blue Box]
Estonian: Karp N20, N30, N50, N60, N100 Hulgipakend sisaldab N200 (2 x 100) [BLUE BOX'IGA]
English: Aluminium/PVC/PE/PVDC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 100 and multipack containing 200 (2 packs of 100) film-coated tablets.
Estonian: Matever, 1000 mg, õhukese polümeerikattega tabletid Alumiinium/PVC/PE/PVDC blistrid pappkarbis, mis sisaldavad 10, 20, 30, 50, 60, 100 ja 200 (2 pakendist koosnev hulgipakend, milles mõlemas 100 tabletti) õhukese polümeerikattega tabletti.
English: Aluminium/PVC/PE/PVDC blisters placed into cardboard boxes containing 20, 30, 50, 60, 100 and multipack containing 200 (2 packs of 100) film-coated tablets.
Estonian: Matever, 250 mg, õhukese polümeerikattega tabletid Alumiinium/PVC/PE/PVDC blistrid pappkarbis, mis sisaldavad 20, 30, 50, 60, 100 ja 200 (2 pakendist koosnev hulgipakend, milles mõlemas 100 tabletti) õhukese polümeerikattega tabletti.
English: The active substance is called levetiracetam.
Estonian: Mida Matever sisaldab Toimeaine on levetiratsetaam.
English: Coating agent (white) consisting of: Hypromellose (E464) Lactose monohydrate Macrogol/PEG 4000
Estonian: Hüpromelloos (E464) Laktoosmonohüdraat Makrogool/PEG 4000 Titaandioksiid (E171)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Estonian: PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI 500 mg/5 ml
English: Matever 100 mg/ml concentrate for solution for infusion.
Estonian: Matever 100 mg/ml infusioonilahuse kontsentraat Levetiratsetaam i.v.
English: Coating agent (orange) consisting of: Hypromellose (E464) Indigo carmine aluminum lake (E132) Sunset yellow FCF aluminum lake (E110) Iron oxide red (E172) Macrogol/PEG 4000
Estonian: Indigokarmiin alumiiniumlakk (E132) Päikeseloojangu kollane FCF alumiiniumlakk (E110) Punane raudoksiid (E172)
English: • nasopharyngitis; • somnolence (sleepiness), headache.
Estonian: • lihasnõrkus, müalgia (lihasvalu); • vigastused.
English: It is available as capsules (4 and 8 mg).
Estonian: Seda turustatakse kapslitena (4 ja 8 mg).
English: The full EPAR for Silodyx can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Silodyxi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Silodyx is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Silodyxi võimalikult ohutu kasutamine.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Silodyx on 29 January 2010.
Estonian: Euroopa Komisjon andis Silodyxi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 29. jaanuaril
English: What measures are being taken to ensure the safe and effective use of Silodyx?
Estonian: Mis meetmed võetakse, et tagada Silodyxi ohutu ja efektiivne kasutamine?
English: They should be swallowed whole, preferably with a glass of water.
Estonian: Need tuleb alla neelata tervelt koos klaasi veega.
English: The patients rated the severity of their symptoms themselves.
Estonian: Nende sümptomite raskusastet hindasid patsiendid ise.
English: The recommended dose is one 8 mg capsule once a day.
Estonian: Soovituslik annus on üks 8 mg kapsel üks kord ööpäevas.
English: The CHMP decided that Silodyx's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Silodyxi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: The main measure of effectiveness in all three studies was the improvement of the patients' international prostate symptom score (IPSS) after 12 weeks of treatment.
Estonian: Efektiivsuse põhinäitaja kõigis kolmes uuringus oli rahvusvahelise eesnäärme sümptomite skoori paranemine 12-nädalase ravi järel.
English: The most common side effect with Silodyx (seen in more than 1 patient in 10) is a reduction in the amount of semen released during ejaculation.
Estonian: Silodyxi kõige sagedam kõrvalnäht (esinenud enam kui 1 patsiendil 10st) on seemnevedeliku hulga vähenemine seemnepurskel.
English: This is a summary of the European public assessment report (EPAR) for Silodyx.
Estonian: See on ravimi Silodyx Euroopa avaliku hindamisaruande kokkuvõte.
English: For more information about treatment with Silodyx, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Silodyxiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: In the two studies where Silodyx was compared only with placebo, the IPSS was around 21 points at the start of the study.
Estonian: Kahes uuringus, milles Silodyxi võrreldi ainult platseeboga, oli rahvusvaheline eesnäärme sümptomite skoor uuringu alguses ümardatuna 21 punkti.
English: In addition, the company that makes Silodyx will ensure that eye surgeons are provided with information on IFIS in all Member States where the medicine will be marketed.
Estonian: Lisaks peab Silodyxi tootja tagama, et silmakirurgidele Euroopa Liidu liikmesriikides, kus ravimit turustatakse, antakse teavet lõdva iirise sündroomist.
English: Silodyx is a medicine that contains the active substance silodosin.
Estonian: Silodyx on ravim, mis sisaldab toimeainena silodosiini.
English: Other information about Silodyx
Estonian: Muu teave Silodyxi kohta
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Silodyx, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati ravimi omaduste kokkuvõttesse ja pakendi infolehele Silodyxi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Silodyx silodosin
Estonian: Silodyx silodosiin
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Silodyx.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: The active substance in Silodyx, silodosin, is an alpha adrenoreceptor antagonist.
Estonian: Silodyxi toimeaine silodosiin on alfa-adrenoretseptorite antagonist.
English: For the full list of all side effects and restrictions with Silodyx, see the package leaflet.
Estonian: Silodyxi kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: When these receptors are activated, they cause the muscles controlling the flow of urine to contract.
Estonian: Nende retseptorite aktiveerumisel tõmbuvad kokku uriini voolamist reguleerivad lihased.
English: What is the risk associated with Silodyx?
Estonian: Mis riskid Silodyxiga kaasnevad?
English: In the third study, IPSS was around 19 points before treatment, falling by 7.0 points in the men who took Silodyx after 12 weeks, 6.7 points in the men who took tamsulosin and 4.7 points in the men who took placebo.
Estonian: Pärast 12-nädalast ravi vähenes see Silodyxi võtnud meestel 7,0 punkti võrra, tamsulosiini võtnud meestel 6,7 punkti võrra ja platseebot võtnud meestel 4,7 punkti võrra.