FrancophonIA/ELRC3.0 huggingface dataset:
English: INFORMATION IN BRAILLE MIRAPEXIN 1.05 mg prolonged-release tablets
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) MIRAPEXIN 1,05 mg toimeainet prolongeeritult vabastavad tabletid
English: INFORMATION IN BRAILLE MIRAPEXIN 0.26 mg prolonged-release tablets
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) MIRAPEXIN 0,26 mg toimeainet prolongeeritult vabastavad tabletid
English: Anhydrous colloidal silica Povidone K 25
Estonian: Veevaba kolloidne ränidioksiid Povidoon K 25
English: INFORMATION IN BRAILLE MIRAPEXIN 3.15 mg prolonged-release tablets
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) MIRAPEXIN 3,15 mg toimeainet prolongeeritult vabastavad tabletid
English: INFORMATION IN BRAILLE MIRAPEXIN 0.52 mg prolonged-release tablets
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) MIRAPEXIN 0,52 mg toimeainet prolongeeritult vabastavad tabletid
English: 1 tablet MIRAPEXIN 0.088 mg three times a day
Estonian: Üks MIRAPEXIN 0,088 mg tablett kolm korda ööpäevas
English: 1 tablet MIRAPEXIN 0.18 mg three times a day OR
Estonian: Üks MIRAPEXIN 0,18 mg tablett kolm korda ööpäevas VÕI
English: MIRAPEXIN 0.18 mg tablets
Estonian: MIRAPEXIN 0,18 mg tabletid
English: Parkinson's disease and are also taking levodopa, you might develop dyskinesia during the up titration of MIRAPEXIN.
Estonian: Parkinsoni tõbi ning te võtate samaaegselt levodopat, siis võib teil tekkida düskineesia.
English: Each prolonged-release tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.05 mg pramipexole.
Estonian: Iga toimeainet prolongeeritult vabastav tablett sisaldab 1,5 mg pramipeksooldivesinikkloriidmonohüdraati, mis vastab 1,05 mg pramipeksoolile.
English: During the first week, the usual dose is 1 tablet MIRAPEXIN 0.088 mg once a day (equivalent to 0.088 mg daily):
Estonian: Esimese nädala jooksul on annuseks üks MIRAPEXIN 0,088 mg tablett üks kord ööpäevas:
English: INFORMATION IN BRAILLE MIRAPEXIN 0.35 mg
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) MIRAPEXIN 0,35 mg
English: - If you get any of the side effects, talk to your doctor or pharmacist.
Estonian: - Kui teil tekib ükskõik milline kõrvaltoime, pidage nõu oma arsti või apteekriga.
English: Also, it can pass into the breast milk and can reach your baby.
Estonian: Samuti võib MIRAPEXIN erituda rinnapiima ning imikusse.
English: INFORMATION IN BRAILLE MIRAPEXIN 1.57 mg prolonged-release tablets
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) MIRAPEXIN 1,57 mg toimeainet prolongeeritult vabastavad tabletid
English: INFORMATION IN BRAILLE MIRAPEXIN 0.18 mg
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) MIRAPEXIN 0,18 mg
English: Talk to your doctor before taking MIRAPEXIN.
Estonian: Enne MIRAPEXIN'i võtmist pidage nõu oma arstiga.
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.088 mg tablets Pramipexole
Estonian: RAVIMPREPARAADI NIMETUS MIRAPEXIN 0,088 mg tabletid Pramipexolum
English: MIRAPEXIN 2.62 mg prolonged-release tablets
Estonian: MIRAPEXIN 2,62 mg toimeainet prolongeeritult vabastavad tabletid.
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 2.62 mg prolonged-release tablets Pramipexole
Estonian: RAVIMPREPARAADI NIMETUS MIRAPEXIN 2,62 mg toimeainet prolongeeritult vabastavad tabletid Pramipexolum
English: INFORMATION IN BRAILLE MIRAPEXIN 0.7 mg
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) MIRAPEXIN 0,7 mg
English: Common: - Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness - Tiredness (fatigue) - Headache - Abnormal dreams - Constipation - Dizziness - Vomiting (being sick)
Estonian: Sage: - Muutused une rütmis, nt unetus (insomnia) ja unisus.
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.35 mg tablets Pramipexole
Estonian: RAVIMPREPARAADI NIMETUS MIRAPEXIN 0,35 mg tabletid Pramipexolum
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 3.15 mg prolonged-release tablets Pramipexole
Estonian: RAVIMPREPARAADI NIMETUS MIRAPEXIN 3,15 mg toimeainet prolongeeritult vabastavad tabletid Pramipexolum
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.52 mg prolonged-release tablets Pramipexole
Estonian: RAVIMPREPARAADI NIMETUS MIRAPEXIN 0,52 mg toimeainet prolongeeritult vabastavad tabletid Pramipexolum
English: INFORMATION IN BRAILLE MIRAPEXIN 2.1 mg prolonged-release tablets
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) MIRAPEXIN 2,1 mg toimeainet prolongeeritult vabastavad tabletid
English: Boehringer Ingelheim RCV GmbH & Co KG Latvijas filiāle
Estonian: Boehringer Ingelheim RCV GmbH & Co KG Latvijās filiale
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 1.05 mg prolonged-release tablets Pramipexole
Estonian: RAVIMPREPARAADI NIMETUS MIRAPEXIN 1,05 mg toimeainet prolongeeritult vabastavad tabletid Pramipexolum
English: Each prolonged-release tablet contains 3.75 mg pramipexole dihydrochloride monohydrate equivalent to 2.62 mg pramipexole.
Estonian: Iga toimeainet prolongeeritult vabastav tablett sisaldab 3,75 mg pramipeksooldivesinikkloriidi monohüdraati, mis vastab 2,62 mg pramipeksoolile.
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.7 mg tablets Pramipexole
Estonian: RAVIMPREPARAADI NIMETUS MIRAPEXIN 0,7 mg tabletid Pramipexolum
English: MIRAPEXIN 1.05 mg prolonged-release tablets
Estonian: MIRAPEXIN 1,05 mg toimeainet prolongeeritult vabastavad tabletid.
English: Parkinson's disease The daily dose is to be taken divided into 3 equal doses.
Estonian: Ööpäevane annus tuleb võtta kolme võrdse annusena.
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 1.57 mg prolonged-release tablets Pramipexole
Estonian: RAVIMPREPARAADI NIMETUS MIRAPEXIN 1,57 mg toimeainet prolongeeritult vabastavad tabletid Pramipexolum
English: Each prolonged-release tablet contains 4.5 mg pramipexole dihydrochloride monohydrate equivalent to 3.15 mg pramipexole.
Estonian: Iga toimeainet prolongeeritult vabastav tablett sisaldab 4,5 mg pramipeksooldivesinikkloriidmonohüdraati, mis vastab 3,15 mg pramipeksoolile.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.26 mg pramipexole.
Estonian: Iga toimeainet prolongeeritult vabastav tablett sisaldab 0,375 mg pramipeksooldivesinikkloriidi monohüdraati, mis vastab 0,26 mg pramipeksoolile.
English: The tablets are white, flat, of round shape, scored on both sides, and have a code embossed (one side with the code P9, and one side with the Boehringer Ingelheim company symbol).
Estonian: Tabletid on valged, lamedad ja ümmargused, mõlemal küljel poolitusjoon ja millele on pressitud kood (ühel küljel kood P9 ja teisel küljel firma Boehringer Ingelheim logo).
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.26 mg prolonged-release tablets Pramipexole
Estonian: RAVIMPREPARAADI NIMETUS MIRAPEXIN 0,26 mg toimeainet prolongeeritult vabastavad tabletid Pramipexolum
English: Each prolonged-release tablet contains 2.25 mg pramipexole dihydrochloride monohydrate equivalent to 1.57 mg pramipexole.
Estonian: Iga toimeainet prolongeeritult vabastav tablett sisaldab 2,25 mg pramipeksooldivesinikkloriidi monohüdraati, mis vastab 1,57 mg pramipeksoolile.
English: Each prolonged-release tablet contains 3 mg pramipexole dihydrochloride monohydrate equivalent to 2.1 mg pramipexole.
Estonian: Iga toimeainet prolongeeritult vabastav tablett sisaldab 3 mg pramipeksooldivesinikkloriidmonohüdraati, mis vastab 2,1 mg pramipeksoolile.
English: Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg pramipexole.
Estonian: Iga tablett sisaldab 1,0 mg pramipeksooldivesinikkloriidi monohüdraati, mis vastab 0,7 mg pramipeksoolile.
English: MIRAPEXIN 3.15 mg prolonged-release tablets
Estonian: MIRAPEXIN 3,15 mg toimeainet prolongeeritult vabastavad tabletid.
English: MIRAPEXIN 0.52 mg prolonged-release tablets
Estonian: MIRAPEXIN 0,52 mg toimeainet prolongeeritult vabastavad tabletid.
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.18 mg tablets Pramipexole
Estonian: RAVIMPREPARAADI NIMETUS MIRAPEXIN 0,18 mg tabletid Pramipexolum
English: Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg pramipexole.
Estonian: Iga tablett sisaldab 0,25 mg pramipeksooldivesinikkloriidi monohüdraati, mis vastab 0,18 mg pramipeksoolile.
English: 4 tablets MIRAPEXIN 0.088 mg
Estonian: Neli MIRAPEXIN 0,088 mg tabletti
English: 1 tablet MIRAPEXIN 0.35 mg
Estonian: Üks MIRAPEXIN 0,35 mg tablett VÕI
English: MIRAPEXIN 1.57 mg prolonged-release tablets
Estonian: MIRAPEXIN 1,57 mg toimeainet prolongeeritult vabastavad tabletid.
English: 6 tablets MIRAPEXIN 0.088 mg
Estonian: Kuus MIRAPEXIN 0,088 mg tabletti
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/025 [10 prolonged-release tablets] EU/1/97/051/026 [30 prolonged-release tablets] EU/1/97/051/027 [100 prolonged-release tablets]
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/97/051/025 [10 toimeainet prolongeeritult vabastavat tabletti] EU/1/97/051/026 [30 toimeainet prolongeeritult vabastavat tabletti] EU/1/97/051/027 [100 toimeainet prolongeeritult vabastavat tabletti]
English: The tablets are white, flat, of oval shape, scored on both sides, and have a code embossed (one side with the code P8, and one side with the Boehringer Ingelheim company symbol).
Estonian: Tabletid on valged, lamedad ja ovaalsed, mõlemal küljel poolitusjoon ja millele on pressitud kood (ühel küljel kood P8, teisel küljel firma Boehringer Ingelheim logo).
English: Pramipexole
Estonian: Pearinglus
English: MIRAPEXIN 2.1 mg prolonged-release tablets
Estonian: MIRAPEXIN 2,1 mg toimeainet prolongeeritult vabastavad tabletid.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/031 [10 prolonged-release tablets] EU/1/97/051/032 [30 prolonged-release tablets] EU/1/97/051/033 [100 prolonged-release tablets]
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/97/051/031 [10 toimeainet prolongeeritult vabastavat tabletti] EU/1/97/051/032 [30 toimeainet prolongeeritult vabastavat tabletti] EU/1/97/051/033 [100 toimeainet prolongeeritult vabastavat tabletti]
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/013 [10 prolonged-release tablets] EU/1/97/051/014 [30 prolonged-release tablets] EU/1/97/051/015 [100 prolonged-release tablets]
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/97/051/013 [10 toimeainet prolongeeritult vabastavat tabletti] EU/1/97/051/014 [30 toimeainet prolongeeritult vabastavat tabletti] EU/1/97/051/015 [100 toimeainet prolongeeritult vabastavat tabletti]
English: Each prolonged-release tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.52 mg pramipexole.
Estonian: Iga toimeainet prolongeeritult vabastav tablett sisaldab 0,75 mg pramipeksooldivesinikkloriidi monohüdraati, mis vastab 0,52 mg pramipeksoolile.
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 2.1 mg prolonged-release tablets Pramipexole
Estonian: RAVIMPREPARAADI NIMETUS MIRAPEXIN 2,1 mg toimeainet prolongeeritult vabastavad tabletid Pramipexolum
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/028 [10 prolonged-release tablets] EU/1/97/051/029 [30 prolonged-release tablets] EU/1/97/051/030 [100 prolonged-release tablets]
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/97/051/028 [10 toimeainet prolongeeritult vabastavat tabletti] EU/1/97/051/029 [30 toimeainet prolongeeritult vabastavat tabletti] EU/1/97/051/030 [100 toimeainet prolongeeritult vabastavat tabletti]
English: MIRAPEXIN 0.26 mg prolonged-release tablets
Estonian: MIRAPEXIN 0,26 mg toimeainet prolongeeritult vabastavad tabletid.
English: 1 tablet MIRAPEXIN 0.088 mg
Estonian: Üks MIRAPEXIN 0,088 mg tablett
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/022 [10 prolonged-release tablets] EU/1/97/051/023 [30 prolonged-release tablets] EU/1/97/051/024 [100 prolonged-release tablets]
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/97/051/022 [10 toimeainet prolongeeritult vabastavat tabletti] EU/1/97/051/023 [30 toimeainet prolongeeritult vabastavat tabletti] EU/1/97/051/024 [100 toimeainet prolongeeritult vabastavat tabletti]
English: 2 tablets MIRAPEXIN 0.088 mg
Estonian: Kaks MIRAPEXIN 0,088 mg tabletti
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/011 [30 tablets]
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/97/051/011 [30 tabletti] EU/1/97/051/012 [100 tabletti]
English: The tablets are white, flat, of round shape, and have a code embossed (one side with the code P6, and one side with the Boehringer Ingelheim company symbol).
Estonian: Tabletid on valged, lamedad ja ümmargused, millele on pressitud kood (ühel küljel kood P6 ja teisel küljel firma Boehringer Ingelheim logo).
English: MIRAPEXIN prolonged-release tablets are a once-a-day oral formulation of pramipexole.
Estonian: MIRAPEXIN toimeainet prolongeeritult vabastavad tabletid on pramipeksooli koostis, mida kasutatakse üks kord ööpäevas suukaudselt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/019 [10 prolonged-release tablets] EU/1/97/051/020 [30 prolonged-release tablets] EU/1/97/051/021 [100 prolonged-release tablets]
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/97/051/019 [10 toimeainet prolongeeritult vabastavat tabletti] EU/1/97/051/020 [30 toimeainet prolongeeritult vabastavat tabletti] EU/1/97/051/021 [100 toimeainet prolongeeritult vabastavat tabletti]
English: Very common: - Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs) - Sleepiness - Dizziness - Nausea (sickness)
Estonian: Düskineesia (st ebanormaalsed ja kontrollimatud jäsemete liigutused) Unisus
English: The tablets are white, flat, of oval shape, scored on both sides, and have a code embossed (one side with the code P7, and one side with the Boehringer Ingelheim company symbol).
Estonian: Tabletid on valged, lamedad ja ovaalsed, mõlemal küljel poolitusjoon ja millele on pressitud kood (ühel küljel kood P7, teisel küljel firma Boehringer Ingelheim logo).
English: 3 tablets MIRAPEXIN 0.18 mg
Estonian: Kolm MIRAPEXIN 0,18 mg tabletti VÕI
English: The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P5, and one side with the Boehringer Ingelheim company symbol).
Estonian: Tabletid on valged või tuhmvalged, ovaalsed ning neile on pressitud kood (ühel küljel P5 ning teisel küljel firma Boehringer Ingelheim logo).
English: 2 tablets MIRAPEXIN 0.18 mg
Estonian: Kaks MIRAPEXIN 0,18 mg tabletti VÕI
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/016 [10 prolonged-release tablets] EU/1/97/051/017 [30 prolonged-release tablets] EU/1/97/051/018 [100 prolonged-release tablets]
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/97/051/016 10 toimeainet prolongeeritult vabastavat tabletti EU/1/97/051/017 30 toimeainet prolongeeritult vabastavat tabletti EU/1/97/051/018 100 toimeainet prolongeeritult vabastavat tabletti
English: The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P13, and one side with the Boehringer Ingelheim company symbol).
Estonian: Tabletid on valged või tuhmvalged, ovaalsed ning neile on pressitud kood (ühel küljel P13 ning teisel küljel firma Boehringer Ingelheim logo).
English: 1 tablet MIRAPEXIN 0.18 mg
Estonian: Üks MIRAPEXIN 0,18 mg tablett VÕI
English: The tablets are white to off-white, of round shape, with bevelled edges, and have a code embossed (one side with the code P1, and one side with the Boehringer Ingelheim company symbol).
Estonian: Tabletid on valged või tuhmvalged, ümmargused, kaldservadega ning neile on pressitud kood (ühel küljel P1 ning teisel küljel firma Boehringer Ingelheim logo).
English: - Vomiting (being sick) - Weight loss including decreased appetite
Estonian: Uuringud kehakaalu langus, sh söögiisu langus;
English: The tablets are white to off-white, of round shape, with bevelled edges, and have a code embossed (one side with the code P2, and one side with the Boehringer Ingelheim company symbol).
Estonian: Tabletid on valged või tuhmvalged, ümmargused, kaldservadega ning neile on pressitud kood (ühel küljel P2 ning teisel küljel firma Boehringer Ingelheim logo).
English: The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P12, and one side with the Boehringer Ingelheim company symbol).
Estonian: Tabletid on valged või tuhmvalged, ovaalsed ning neile on pressitud kood (ühel küljel P12 ning teisel küljel firma Boehringer Ingelheim logo).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/005 [30 tablets]
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/97/051/005 [30 tabletti] EU/1/97/051/006 [100 tabletti]
English: The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P3, and one side with the Boehringer Ingelheim company symbol).
Estonian: Tabletid on valged või tuhmvalged, ovaalsed ning neile on pressitud kood (ühel küljel P3 ning teisel küljel firma Boehringer Ingelheim logo).
English: The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P4, and one side with the Boehringer Ingelheim company symbol).
Estonian: Tabletid on valged või tuhmvalged, ovaalsed ning neile on pressitud kood (ühel küljel P4 ning teisel küljel firma Boehringer Ingelheim logo).
English: Renal impairment
Estonian: Unetus (insomnia)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/003 [30 tablets]
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/97/051/003 [30 tabletti] EU/1/97/051/004 [100 tabletti]
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/001 [30 tablets]
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/97/051/001 [30 tabletti] EU/1/97/051/002 [100 tabletti]
English: 40 (1 cartridge x 40) tablets
Estonian: Pakendi suurus kolbampull (PC) 40 (1 kolbampull x 40) tabletti
English: EU number
Estonian: Müügiloa nr Euroopa Liidus Nimi
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Estonian: (Väljamõeldud) nimetus
English: All indications are not authorised in all EU MS.
Estonian: Kõik näidustused ei ole kõigis Euroopa Liidu liikmesriikides heaks kiidetud.
English: These constitute the majority of the available evidence, in particular in the indications that were first authorised (e.g. secretolytic indication).
Estonian: Need moodustavad enamiku olemasolevatest tõenditest, eriti esimestena heakskiidetud näidustuste korral (nt sekretolüütiline näidustus).
English: Only these amendments, adopted and included in the CMDh position, are legally binding and must be implemented by the Member States.
Estonian: Ainult muudatused, mis on heaks kiidetud ja sisalduvad kooskõlastusrühma seisukohas, on õiguslikult siduvad ning liikmesriigid peavad need rakendama.
English: The CMDh position was forwarded to the European Commission.
Estonian: Kooskõlastusrühma seisukoht edastati Euroopa Komisjonile.
English: The PRAC noted that the worldwide estimated exposure of the originator's products alone is over 50 million patient-years and, in the EU over the last decade, around 6.8 million patient-years.
Estonian: Ravimiohutuse riskihindamise komitee märkis, et maailmas on hinnanguline kokkupuude ainuüksi originaalravimiga üle 50 miljoni patsiendiaasta ja Euroopa Liidus viimasel aastakümnel ligikaudu 6,8 miljonit patsiendiaastat.
English: It is acknowledged that most of the indications are supported by old studies presenting limitations and deficiencies.
Estonian: Enamikku näidustusi toetavad vanad uuringud, milles on piiranguid ja puudusi.
English: Further, the definition of the relevant clinical endpoints and the measurement of symptoms in these conditions are challenging (Rubin, 2007).
Estonian: Lisaks tekitavad probleeme asjakohaste kliiniliste tulemusnäitajate määratlemine ja selliste haiguste sümptomite hindamine (Rubin 2007).
English: Ambroxol- and bromhexine-containing medicinal products have first been registered in a European Union (EU) Member State (MS) in 1978 and 1963, respectively, and are currently authorised in all EU MSs (as well as in Norway and Iceland) except the United Kingdom.
Estonian: Ambroksooli ja broomheksiini sisaldavad ravimid registreeriti Euroopa Liidu liikmesriigis esimest korda aastatel 1978 ja 1963 ning praegu on need heaks kiidetud kõigis Euroopa Liidu liikmesriikides (samuti Norras ja Islandil), välja arvatud Ühendkuningriigis.
English: Consequently the PSUR cycle should be shortened to a 3-yearly cycle in order to periodically review these analyses.
Estonian: Seega tuleb perioodiliste ohutusaruannete tsüklit lühendada 3 aastale, et analüüse regulaarselt üle vaadata.
English: Most often these patients receive a number of drugs concomitantly and causality assessment is difficult.
Estonian: Enamasti manustatakse neile patsientidele samal ajal mitut ravimit ja põhjuslikku seost on hinnata keerukas.
English: Based on its clinical experience, the PDCO was of the view that there is no need for the use of these products in this indication in children below 2 years of age.
Estonian: Oma kliinilisele kogemusele toetudes leidis pediaatriakomitee, et sellel näidustusel ei ole vaja kasutada neid ravimeid alla 2-aastastel lastel.
English: Of note, drugs started less than 4 days or more than 8 weeks before the onset of the reaction are unlikely to be responsible.
Estonian: Nahareaktsioone tõenäoliselt ei põhjusta ravimid, mille manustamist on alustatud vähem kui 4 päeva või rohkem kui 8 nädalat enne reaktsiooni teket.
English: It is acknowledged that clinical evidence from studies in children is weak due to their heterogeneity and to the lower number of children enrolled.
Estonian: Laste uuringutest pärit kliinilised tõendid olid heterogeensuse ja osalenud laste väikese arvu tõttu ebausaldusväärsed.
English: For these reasons studies conducted after the initial marketing authorisation do not provide new significant scientific data on the efficacy of the products.
Estonian: Nendel põhjustel ei saa pärast algset müügiloa andmist tehtud uuringutest uusi olulisi teaduslikke andmeid ravimite efektiivsuse kohta.
English: 1 - Overall summary of the scientific evaluation by the PRAC Safety issues
Estonian: 1 - Ravimiohutuse riskihindamise komitee teadusliku hindamise üldkokkuvõte
English: The clinical studies performed during the development of bromhexine- and ambroxol-containing products between the 1950ies and 1980ies were considerably less standardised than would be necessary today, and would not completely fulfil contemporary requirements with regard to validated endpoints, statistical confirmation, or Good Clinical Practice (GCP).
Estonian: Broomheksiini ja ambroksooli väljatöötamise kliinilised uuringud 1950.-1980. aastatel olid praegustest nõuetest oluliselt vähem standardiseeritud ega vasta täielikult tänapäevastele valideeritud tulemusnäitajate, statistilise kinnitamise või hea kliinilise tava nõuetele.
English: During the decision making process, at a meeting of the Standing Committee on Medicinal Products for Human Use, some Member States raised new questions of technical nature which they considered had not been sufficiently addressed in the PRAC recommendation and CMDh position.
Estonian: Asja otsustamisel inimravimite alalise komitee koosolekul tõstatas mõni liikmesriik uusi tehnilisi küsimusi, mis nende arvates ei olnud piisavalt lahendatud ravimiohutuse riskihindamise komitee soovituses ning kooskõlastusrühma seisukohas.
English: This is not unexpected considering the methodological challenges inherent to this therapeutic area and evidential standards and requirements at the time when these products were first developed.
Estonian: Seda võib mõneti eeldada, arvestades selle ravivaldkonna olemuslikke metoodikaprobleeme ning ravimite esmase väljatöötamise ajal tõendite suhtes kehtinud standardeid ja nõudeid.
English: Many drug reactions cannot be distinguished from naturally occurring or infection-induced eruptions, and thus misdiagnosis is common.
Estonian: Paljusid ravimireaktsioone ei saa eristada ravimiga mitteseotud või infektsioonidest põhjustatud löövetest, mille tõttu esineb sageli väärdiagnoose.
English: In addition, the PRAC discussed the need to conduct post-authorisation studies, and concluded that such studies would likely not generate new robust information towards more definite conclusions.
Estonian: Lisaks arutas ravimiohutuse riskihindamise komitee vajadust korraldada müügiloa andmise järgseid uuringuid ja leidis, et tõenäoliselt ei saa sellistest uuringutest uut usaldusväärset teavet, mille alusel teha kindlamaid järeldusi.