FrancophonIA/ELRC3.0 huggingface dataset:
English: Very rare (may affect up to 1 in 10,000 people)
Estonian: Väga harv (võib mõjutada kuni 1 patsienti 10 000-st)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTERS
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED BLISTERKARP
English: • if you have, or have ever had, difficulties in passing urine.
Estonian: • kui teil on või on kunagi olnud urineerimisraskusi.
English: Each Rivastigmine Actavis 6 mg capsule contains 6 mg of rivastigmine.
Estonian: Üks Rivastigmine Actavis'e 6 mg kapsel sisaldab 6 mg rivastigmiini.
English: No dose adjustment is necessary for patients with mild to moderate renal or hepatic impairment.
Estonian: Kerge kuni mõõduka neeru- või maksakahjustusega patsientidel ei ole vaja annust muuta.
English: Rivastigmine Actavis is used for the treatment of adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Estonian: See on süvenev ajuhäire, mis järk-järgult mõjutab mälu, intellektuaalset võimekust ja käitumist.
English: Mean change at 24 weeks 2.1 ± 8.2 ± SD
Estonian: Keskmine muutus 24 nädalal ± SD
English: Magnesium stearate Silica colloidal, anhydrous Hypromellose Microcrystalline cellulose
Estonian: Magneesiumstearaat Kolloidne veevaba ränidioksiid Hüpromelloos
English: Each Rivastigmine Actavis 4.5 mg capsule contains 4.5 mg of rivastigmine.
Estonian: Üks Rivastigmine Actavis'e 4,5 mg kapsel sisaldab 4,5 mg rivastigmiini.
English: There is no relevant use of rivastigmine in the paediatric population in the treatment of Alzheimer's disease.
Estonian: Puudub rivastigmiini asjakohane kasutamine lastel Alzheimeri tõve ravis.
English: Each Rivastigmine Actavis 1.5 mg capsule contains 1.5 mg of rivastigmine.
Estonian: Üks Rivastigmine Actavis'e 1,5 mg kapsel sisaldab 1,5 mg rivastigmiini.
English: Other side effects seen with rivastigmine transdermal patches and which may occur with the hard capsules:
Estonian: Teised rivastigmiini transdermaalse plaastri kõrvaltoimed ja kõvakapsli kõrvaltoimed:
English: INFORMATION IN BRAILLE Rivastigmine Actavis 1.5 mg
Estonian: INFORMATSIOON BRAILLE' KIRJAS (PUNKTKIRJAS) rivastigmine actavis 1,5 mg
English: Rivastigmine Actavis 1.5 mg hard capsules Titanium dioxide (E171) Yellow iron oxide (E172) Gelatine
Estonian: Rivastigmine Actavis 1.5 mg kõvakapslid Titaandioksiid (E171) Kollane raudoksiid (E172) Želatiin
English: Each Rivastigmine Actavis 3 mg capsule contains 3 mg of rivastigmine.
Estonian: Üks Rivastigmine Actavis'e 3 mg kapsel sisaldab 3 mg rivastigmiini.
English: The Cmax of rivastigmine was approximately 60 % higher and the AUC of rivastigmine was more than twice as high in subjects with mild to moderate hepatic impairment than in healthy subjects.
Estonian: Kerge kuni keskmise maksakahjustusega isikutel oli rivastigmiini Cmax ligikaudu 60% suurem ja rivastigmiini AUC üle kahe korra suurem kui tervetel.
English: INFORMATION IN BRAILLE Rivastigmine Actavis 6 mg
Estonian: INFORMATSIOON BRAILLE' KIRJAS (PUNKTKIRJAS) rivastigmine actavis 6 mg
English: INFORMATION IN BRAILLE Rivastigmine Actavis 4.5 mg
Estonian: INFORMATSIOON BRAILLE' KIRJAS (PUNKTKIRJAS) rivastigmine actavis 4,5 mg
English: • if you have, or have ever had impaired kidney function.
Estonian: • kui teil on või on kunagi olnud neerufunktsiooni langus.
English: Rivastigmine Actavis 1.5 mg hard capsules
Estonian: Rivastigmine Actavis 1.5 mg kõvakapslid
English: Capsule shell: Rivastigmine Actavis 1.5 mg hard capsules: Titanium dioxide (E171), yellow iron oxide (E172) and gelatine.
Estonian: Kapsli kate: Rivastigmine Actavis 1.5 mg kõvakapslid: titaandioksiid (E171), kollaneraudoksiid (E172) ja želatiin.
English: Table 5
Estonian: Tabel 5.
English: • Inflammation of the pancreas - the signs include serious upper stomach pain, often with feeling sick (nausea) or being sick (vomiting)
Estonian: • kõhunäärmepõletik - sümptomiteks on tugev ülakõhuvalu, halb enesetunne (iiveldus) või haiglane olek (oksendamine)
English: Rivastigmine Actavis 4.5 mg hard capsules
Estonian: Rivastigmine Actavis 4.5 mg kõvakapslid
English: Efficacy has been established by the use of two independent scales which were assessed at regular intervals during a 6-month treatment period as shown in Table 5 below: the ADAS-Cog, a measure of cognition, and the global measure ADCS-CGIC (Alzheimer's Disease Cooperative StudyClinician's Global Impression of Change).
Estonian: Efektiivsust tõestati regulaarsete intervallide järel 6-kuulise raviperioodi jooksul kahe iseseisva skaala abil nagu on näidatud allpool tabelis 5: kognitiivsuse määr
English: • if you have gastrointestinal reactions such as feeling sick (nausea), being sick (vomiting) and diarrhoea.
Estonian: • kui teil esinevad seedetrakti häired nagu halb enesetunne (iiveldus), haiglane olek
English: INFORMATION IN BRAILLE Rivastigmine Actavis 3 mg
Estonian: INFORMATSIOON BRAILLE' KIRJAS (PUNKTKIRJAS) rivastigmine actavis 3 mg
English: Rivastigmine Actavis 6 mg hard capsules
Estonian: Rivastigmine Actavis 6 mg kõvakapslid
English: • Chest pain
Estonian: • rindkere valu
English: - Rivastigmine Actavis 4.5 mg hard capsules, which contain off-white to slightly yellow powder, have a red cap and red body, with white imprint “RIV 4.5mg” on body.
Estonian: - Rivastigmine Actavis 4,5 mg kõvakapsel, mis sisaldab peaaegu valget kuni helekollast värvi pulbrit punase kaane ja punase kapslikehaga kõvakapslis, kehal on valge kiri „RIV 4,5mg“.
English: Off-white to slightly yellow powder in a hard capsule with yellow cap and yellow body, with red imprint “RIV 1.5mg” on body.
Estonian: Peaaegu valget kuni helekollast värvi pulber kollase kapsli kaane ja kollase kapsli kehaga kõvakapslis, kapsli kehale on punasega trükitud „RIV 1,5mg“.
English: - Rivastigmine Actavis 3 mg hard capsules, which contain off-white to slightly yellow powder, have an orange cap and orange body, with red imprint “RIV 3mg” on body.
Estonian: - Rivastigmine Actavis 3 mg kõvakapsel, mis sisaldab peaaegu valget kuni helekollast värvi pulbrit oranži kaane ja oranži kapslikehaga kõvakapslis, kehal on punane kiri „RIV 3mg“.
English: DATE OF REVISION OF THE TEXT
Estonian: Seisundi käsitlemine
English: Titanium dioxide (E171) Yellow iron oxide (E172) Gelatine
Estonian: Titaandioksiid (E171)
English: Rivastigmine Actavis 3 mg hard capsules
Estonian: Rivastigmine Actavis 3 mg kõvakapslid
English: Rivastigmine Actavis 6 mg hard capsules EU/1/11/693/013
Estonian: Rivastigmine Actavis 6 mg kõvaksplid EU/1/11/693/013
English: • Fits (seizures)
Estonian: • krambihood (krambid)
English: - Rivastigmine Actavis 6 mg hard capsules, which contain off -white to slightly yellow powder, have an red cap and orange body, with red imprint “RIV 6mg” on body.
Estonian: - Rivastigmine Actavis 6 mg kõvakapsel, mis sisaldab peaaegu valget kuni helekollast värvi pulbrit punase kaane ja oranži kapslikehaga kõvakapslis, kehal on punane kiri „RIV 6mg“.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 6 mg rivastigmine (as hydrogen tartrate).
Estonian: TOIMEAINE(TE) SISALDUS 1 kapsel sisaldab 6 mg rivastigmiini (vesiniktartraadina).
English: There is no relevant use of Rivastigmine Actavis in the paediatric population in the treatment of Alzheimer's disease.
Estonian: Lapsed ja noorukid Rivastigmine Actavis'e kasutamine Alzheimer'i tõve raviks lastel ei ole asjakohane.
English: Reykjavíkurvegur 76 - 78 IS-220 Hafnarfjördur Iceland
Estonian: Reykjavíkurvegur 76 - 78 IS-220 Hafnarfjörður Island
English: associated with Parkinson's disease Total patients studied Total patients with pre-defined AE(s) Tremor
Estonian: patsientidel parkinsonismi sümptomite ägenemisele Kõik uuritud patsiendid
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 1.5 mg rivastigmine (as hydrogen tartrate).
Estonian: TOIMEAINE(TE) SISALDUS 1 kapsel sisaldab 1,5 mg rivastigmiini (vesiniktartraadina).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 4.5 mg rivastigmine (as hydrogen tartrate).
Estonian: TOIMEAINE(TE) SISALDUS 1 kapsel sisaldab 4,5 mg rivastigmiini (vesiniktartraadina).
English: Reykjavíkurvegur 76-78 220 Hafnarfjörður Iceland
Estonian: Reykjavíkurvegur 76-78 220 Hafnarfjörður Island
English: Rivastigmine Actavis 4.5 mg hard capsules EU/1/11/693/009
Estonian: Rivastigmine Actavis 4.5 mg kõvaksplid EU/1/11/693/009
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/004
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/11/693/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/012
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/11/693/012
English: Rivastigmine Placebo Rivastigmine Placebo ITT + RDO population (n=329)
Estonian: ITT + RDO populatsioon (n=329)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/008
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/11/693/008
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 3 mg rivastigmine (as hydrogen tartrate).
Estonian: TOIMEAINE(TE) SISALDUS 1 kapsel sisaldab 3 mg rivastigmiini (vesiniktartraadina).
English: Common (may affect up to 1 in 10 people)
Estonian: Sage (võib mõjutada kuni 1 patsienti 10-st)
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Actavis 1.5 mg hard capsules rivastigmine
Estonian: RAVIMPREPARAADI NIMETUS Rivastigmine Actavis 1,5 mg kõvakapslid Rivastigminum
English: No untoward effects on cardiac conduction were observed following concomitant administration of digoxin and rivastigmine.
Estonian: Digoksiini ja rivastigmiini koosmanustamisel ei täheldatud kahjustavat toimet südame juhtesüsteemile.
English: Rivastigmine Actavis 1.5 mg hard capsules EU/1/11/693/001
Estonian: Rivastigmine Actavis 1.5 mg kõvaksplid EU/1/11/693/001
English: Uncommon (may affect up to 1 in 100 people)
Estonian: Aeg-ajalt (võib mõjutada kuni 1 patsienti 100-st)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/016
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/11/693/016
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR CAPSULE CONTAINER
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED TABLETIPURGI KARP
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Actavis 4.5 mg hard capsules rivastigmine
Estonian: RAVIMPREPARAADI NIMETUS Rivastigmine Actavis 4,5 mg kõvakapslid Rivastigminum
English: Rivastigmine Actavis 3 mg hard capsules EU/1/11/693/005
Estonian: Rivastigmine Actavis 3 mg kõvaksplid EU/1/11/693/005
English: Propylene glycol
Estonian: Mikrokristalliline tselluloos
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Actavis 6 mg hard capsules rivastigmine
Estonian: RAVIMPREPARAADI NIMETUS Rivastigmine Actavis 6 mg kõvakapslid Rivastigminum
English: Gastric and duodenal ulcers
Estonian: Mao- ja kaksteistsõrmikuhaavandid
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Actavis 3 mg hard capsules rivastigmine
Estonian: RAVIMPREPARAADI NIMETUS Rivastigmine Actavis 3 mg kõvakapslid Rivastigminum
English: Patients with Clinically Significant Response (%) Intent to Treat
Estonian: Kliiniliselt olulise vastusreaktsiooniga patsiendid (%) Ravitud patsiendid Viimane hinnatud näitaja Vastusreaktsiooni näitaja Rivastigmiin Platseebo Rivastigmiin Platseebo 6-12 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/013[ 28 blister]
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/11/693/013 [ 28 blister] EU/1/11/693/014 [56 blister] EU/1/11/693/015 [112 blister]
English: Table 4
Estonian: Tabel 4.
English: • if you have, or have ever had, impaired liver function.
Estonian: • kui teil on või on kunagi olnud maksafunktsiooni langus.
English: • if you have, or have ever had, an active stomach ulcer.
Estonian: • kui teil on või on kunagi olnud äge maohaavand.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/005[ 28 blister]
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/11/693/005 [ 28 blister] EU/1/11/693/006 [56 blister] EU/1/11/693/007 [112 blister]
English: Tabulated list of adverse reactions
Estonian: Kõrvaltoimete loetelu tabel
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/009[ 28 blister]
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/11/693/001[ 28 blister] EU/1/11/693/002 [56 blister] EU/1/11/693/003 [112 blister]
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 1.5 mg rivastigmine.
Estonian: Rivastigmine Actavis 1.5 mg kõvakapslid Üks kapsel sisaldab rivastigmiinvesiniktartraati, mis vastab 1,5 mg rivastigmiinile.
English: Rare (may affect up to 1 in 1,000 people)
Estonian: Harv (võib mõjutada kuni 1 patsienti 1000-st)
English: Off-white to slightly yellow powder in a hard capsule with orange cap and orange body, with red imprint “RIV 3mg” on body.
Estonian: Peaaegu valget kuni helekollast värvi pulber oranži kapsli kaane ja oranži kapsli kehaga kõvakapslis,
English: 10 (2 x 5) prefilled pens (multipack)
Estonian: 10 (2 x 5) pensüstlit (mitmikpakend)
English: 1 pre-filled pen + 7 NovoTwist needles
Estonian: 1 pen-süstel + 7 NovoTwist nõela
English: 1 pre-filled pen + 7 NovoFine needles
Estonian: 1 pen-süstel + 7 NovoFine nõela
English: 5 pre-filled pens
Estonian: 5 pen-süstlit
English: What is the outcome of the review?
Estonian: Mis on selle ülevaatuse tulemus?
English: The European Commission issued an EU-wide legally binding decision to implement these changes on 2 August 2018.
Estonian: Euroopa Komisjon tegi nende muudatuste rakendamiseks kogu Euroopa Liidus õiguslikult siduva otsuse 2. augustil 2018.
English: The package leaflet will be updated accordingly.
Estonian: Pakendi infolehte uuendatakse vastavalt.
English: What is Scandonest?
Estonian: Mis on Scandonest?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom2 August 2018
Estonian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom2.
English: The review was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use.
Estonian: Läbivaatamise tegi EMA inimravimite komitee, kes vastutab inimravimitega seotud küsimuste eest.
English: In addition, it must not be used in children below 4 years of age, in patients with severe problems affecting the heart's electrical activity which are not resolved by a pace-maker, and in epileptic patients whose disease is not adequately controlled.
Estonian: Lisaks ei tohi seda kasutada alla 4-aastaste laste puhul, patsientide puhul, kellel esineb raskeid probleeme, mis mõjutavad südame elektrilist aktiivsust ja mida ei lahenda südamestimulaator, ning epileptiliste patsientide puhul, kelle haigus ei ole piisava kontrolli all.
English: After review of the available data, a number of other contraindications which were only valid in some countries were considered not to be supported by sufficient data, or to be redundant and already included in the current list above.
Estonian: Pärast kättesaadavate andmete ülevaatust ei loetud mitmeid teisi vastunäidustusi, mis kehtisid vaid mõnes riigis, piisavate andmete poolt toetatuks või loeti need üleliigseteks ja juba loetelus esindatuteks.
English: Scandonest is also available in the EU under the trade names Biocaine and Scandicaine.
Estonian: Scandonesti turustatakse Euroopa Liidus ka nimetuste Biocaine ja Scandicaine all.
English: The recommended dose of Scandonest depends on the patient's age and body weight.
Estonian: Scandonesti soovituslik annus sõltub patsiendi vanusest ja kehakaalust.
English: Why was Scandonest reviewed?
Estonian: Miks Scandonesti ravimiteave uuesti läbi vaadati?
English: Scandonest has been authorised in the EU via national procedures.
Estonian: Scandonest on saanud Euroopa Liidus müügiloa riiklike menetluste kaudu.
English: Other harmonised sections of the SmPC include sections 4.4 (special warnings and precautions for use) 4.5 (interactions), 4.6 (fertility, pregnancy and lactation), 4.7 (effects on ability to drive and use machines), and 4.8 (side effects).
Estonian: Teiste ravimiomaduste kokkuvõttes ühtlustatud lõikude alla kuuluvad lõigud 4.4 (erihoiatused ja ettevaatusabinõud kasutamisel), 4.5 (koostoimed), 4.6 (fertiilsus, rasedus ja imetamine), 4.7 (autojuhtimise ja masinate käsitsemise võime) ja 4.8 (kõrvaltoimed).
English: The review of Scandonest was initiated at the request of the marketing authorisation holder, Septodont, under Article 30 of Directive 2001/83/EC.
Estonian: Scandonesti läbivaatamine algatati müügiloa hoidja Septodonti taotlusel vastavalt direktiivi 2001/83/EÜ artiklile 30.
English: In addition, Module 3 of the medicine dossier (which describes how the medicine is produced and its quality controlled) has also been harmonised.
Estonian: Lisaks on ühtlustatud ka ravimi toimiku (kirjeldab ravimi tootmist ja kvaliteedi kontrolli) moodulit 3.
English: Use of Scandonest and associated names (mepivacaine) to be harmonised EMA/533239/2018
Estonian: Scandonesti ja sarnaste nimetuste (mepivakaiin) kasutuse ühtlustamine EMA/533239/2018
English: This has led to inconsistency across Member States in the way the medicine is produced and can be used, as seen in the differences in the prescribing information [summary of product characteristics (SmPC), labelling and package leaflet] in the countries where the medicine is marketed.
Estonian: See on toonud kaasa ebakõlad liikmesriikide vahel seoses viisiga, kuidas ravimit toodetakse ja kasutatakse, ning see avaldub ravimit turustavate riikide ravimiteabe erinevustes [ravimi omaduste kokkuvõte, märgistus ja pakendi infoleht].
English: Scandonest is now authorised for use as local anaesthetic in dental surgery in adults, adolescents and children above 4 years of age (weighing around 20 kg).
Estonian: Scandonesti võib nüüd kasutada kohaliku tuimestina täiskasvanute, noorukite ja üle 4-aastaste laste (kaaluga ligi 20 kg) hambakirurgias.
English: On 25 August 2017, Septodont, the company that markets Scandonest, referred the matter to EMA in order to harmonise the marketing authorisations for Scandonest in the EU.
Estonian: 25. augustil 2017 edastas Scandonesti turustav ettevõte Septodont probleemi EMA-le, et ühtlustada Scandonesti müügilube Euroopa Liidus.
English: On 31 May 2018, the European Medicines Agency (EMA) completed a review of Scandonest and associated names and recommended changes to the prescribing information in order to harmonise the way the medicine is used in the EU.
Estonian: 31. mail 2018 valmis Euroopa Ravimiametil (EMA) Scandonesti ja sarnaste nimetuste läbivaatamine ja soovitati muuta nende ravimiteavet, et ühtlustada viisi, kuidas ravimit ELis kasutatakse.
English: It contains the active substance mepivacaine.
Estonian: Ravim sisaldab toimeainena mepivakaiini.
English: Where justified by data, some of the previous contraindications have been included in section 4.4 Special warnings and precautions for use.
Estonian: Andmete poolt toetatud juhtudel hõlmati mõned varasemad vastunäidustused lõiku 4.4 „Erihoiatused ja ettevaatusabinõud kasutamisel“.
English: Scandonest should no longer be used as local anaesthetic during chiropody procedures (treatment of corns, verrucae, etc.), because the data presented by the company were considered not sufficient to support this use.
Estonian: Scandonesti ei tohi enam kasutada kohaliku tuimestina kiropoodiaprotseduuride (konnasilmade, soolatüügaste jms ravi) ajal, kuna ettevõtte esitatud andmeid ei loetud piisavaks, et sellist kasutust toetada.
English: After considering the available data on the use of Scandonest, the Agency concluded that the SmPC should be harmonised.
Estonian: Pärast Scandonesti kasutuse kohta kättesaadavate andmete arvesse võtmist järeldas amet, et ravimi omaduste kokkuvõtet tuleb ühtlustada.
English: Scandonest is a local anaesthetic, a medicine used to block sensation and pain in part of the body during medical procedures.
Estonian: Scandonest on kohalik tuimesti, ravim, mida kasutatakse meditsiiniliste protseduuride ajal, et blokeerida teatud kehaosas tunnetus ja valu.
English: Use of Scandonest and associated names (mepivacaine) to be harmonised
Estonian: Scandonesti ja sarnaste nimetuste (mepivakaiin) kasutuse ühtlustamine
English: Scandonest must not be used in patients who are allergic to the active substance mepivacaine or any of the other ingredients of the medicine.
Estonian: Scandonesti ei tohi kasutada patsientidel, kes on toimeaine mepivakaiini või ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: The company that markets these medicines is Septodont.
Estonian: Neid ravimeid turustab ettevõte Septodont.
English: Information for doctors and patients to be aligned across EU
Estonian: Kogu Euroopa Liidus ühtlustatav teave arstidele ja patsientidele
English: In adults, the maximum recommended dose is 4.4 mg per kg body weight, up to a maximum total dose of 300 mg.
Estonian: Täiskasvanute puhul on maksimaalne soovitatav annus 4,4 mg kehakaalu kg kohta, maksimaalne koguannus on 300 mg. Laste puhul on soovitatav annus 0,75 mg/kg.
English: Scandonest is given by injection.
Estonian: Scandonesti manustatakse süstena.
English: The areas harmonised include:
Estonian: Ühtlustatavad valdkonnad on järgmised: 4.1 Näidustused
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Estonian: Ravimpreparaadi nimetus Tugevus Ravimvorm Manustamisviis
English: The European Commission granted a marketing authorisation valid throughout the European Union for NovoThirteen on 3 September 2012.
Estonian: Euroopa Komisjon andis NovoThirteeni müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 3. septembril 2012.
English: The recommended dose is 35 international units (IU) per kilogram body weight once per month.
Estonian: Soovituslik annus on 35 rahvusvahelist ühikut (IU) kehakaalu kilogrammi kohta üks kord kuus.
English: The condition must be confirmed by suitable tests before starting treatment.
Estonian: Seisund tuleb enne ravi alustamist kinnitada vastavate testidega.
English: The full EPAR for NovoThirteen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst NovoThirteeni 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 NovoThirteen is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada NovoThirteeni võimalikult ohutu kasutamine.
English: What measures are being taken to ensure the safe and effective use of NovoThirteen?
Estonian: Mis meetmed võetakse, et tagada NovoThirteeni ohutu ja efektiivne kasutamine?
English: NovoThirteen catridecacog
Estonian: NovoThirteen katridekakoog
English: This is a summary of the European public assessment report (EPAR) for NovoThirteen.
Estonian: See on ravimi NovoThirteen Euroopa avaliku hindamisaruande kokkuvõte.
English: Other information about NovoThirteen
Estonian: Muu teave NovoThirteeni kohta
English: The CHMP concluded that the main study provided satisfactory results in terms of effectiveness, since no severe or life-threatening bleedings took place during treatment with NovoThirteen.
Estonian: Inimravimite komitee järeldas, et põhiuuring andis efektiivsuse kohta rahuldavaid tulemusi, sest ravi ajal NovoThirteeniga ei esinenud raskeid või eluohtlikke verejookse.
English: This is an inherited blood clotting disorder characterised by bleeding episodes.
Estonian: See on pärilik verehüübimise häire, mida iseloomustavad veritsusepisoodid.
English: The study was extended for a further year in 33 of the patients, to look at the long-term safety of treatment with NovoThirteen.
Estonian: Uuringut pikendati 33 patsiendil ühe aasta võrra, et hinnata NovoThirteeni ravi pikaajalist ohutust.
English: Moreover, no major side effects were seen with long term use of NovoThirteen.
Estonian: Lisaks ei täheldatud NovoThirteeni pikaajalisel kasutamisel raskeid kõrvalnähte.
English: Additionally, the company that markets NovoThirteen will provide all doctors who are expected to prescribe it with an information pack for doctors and patients containing important information on the correct use of the medicine.
Estonian: Lisaks varustab ettevõte, mis turustab NovoThirteeni, ravimit määravad arstid ja patsiendid teabepakmega, mis sisaldab olulist teavet selle ravimi õige kasutamise kohta.