FrancophonIA/ELRC3.0 huggingface dataset:
English: INFORMATION IN BRAILLE MIRAPEXIN 0.35 mg
Slovenian: PODATKI V BRAILLOVI PISAVI MIRAPEXIN 0,35 mg
English: MIRAPEXIN 3.15 mg prolonged-release tablets
Slovenian: MIRAPEXIN 3,15 mg tablete s podaljšanim sproščanjem pramipeksol
English: MIRAPEXIN 2.1 mg prolonged-release tablets EU/1/97/051/022-024
Slovenian: MIRAPEXIN 2,1 mg tablete s podaljšanim sproščanjem EU/1/97/051/022-024
English: MIRAPEXIN 3.15 mg prolonged-release tablets EU/1/97/051/025-027
Slovenian: MIRAPEXIN 3,15 mg tablete s podaljšanim sproščanjem EU/1/97/051/025-027
English: INFORMATION IN BRAILLE MIRAPEXIN 0.26 mg prolonged-release tablets
Slovenian: PODATKI V BRAILLOVI PISAVI MIRAPEXIN 0,26 mg tablete s podaljšanim sproščanjem
English: MIRAPEXIN 0.18 mg tablets
Slovenian: MIRAPEXIN 0,18 mg tablete
English: EU/1/97/051/012 [100 tablets]
Slovenian: EU/1/97/051/012 [100 tablet]
English: INFORMATION IN BRAILLE MIRAPEXIN 1.05 mg prolonged-release tablets
Slovenian: PODATKI V BRAILLOVI PISAVI MIRAPEXIN 1,05 mg tablete s podaljšanim sproščanjem
English: MIRAPEXIN 1.05 mg prolonged-release tablets EU/1/97/051/019-021
Slovenian: MIRAPEXIN 1,05 mg tablete s podaljšanim sproščanjem EU/1/97/051/019-021
English: 3 tablets MIRAPEXIN 0.18 mg
Slovenian: 3 tablete zdravila MIRAPEXIN po 0,18 mg
English: 6 tablets MIRAPEXIN 0.088 mg
Slovenian: 6 tablet zdravila MIRAPEXIN po 0,088 mg
English: INFORMATION IN BRAILLE MIRAPEXIN 3.15 mg prolonged-release tablets
Slovenian: PODATKI V BRAILLOVI PISAVI MIRAPEXIN 3,15 mg tablete s podaljšanim sproščanjem
English: INFORMATION IN BRAILLE MIRAPEXIN 0.52 mg prolonged-release tablets
Slovenian: PODATKI V BRAILLOVI PISAVI MIRAPEXIN 0,52 mg tablete s podaljšanim sproščanjem
English: In patients with a creatinine clearance between 30 and 50 ml/min, treatment should be started with 0.26 mg MIRAPEXIN prolonged-release tablets every other day.
Slovenian: Bolnike s kreatininskim očistkom 30 do 50 ml/min začnemo zdraviti z MIRAPEXIN 0,26 mg tabletami s podaljšanim sproščanjem vsak drugi dan. Preden odmerek po enem tednu previdno povečamo na dnevni odmerek, je treba natančno oceniti odzivanje na zdravljenje in prenašanje.
English: 1 tablet MIRAPEXIN 0.35 mg
Slovenian: 1 tableta zdravila MIRAPEXIN po 0,35 mg in
English: INFORMATION IN BRAILLE MIRAPEXIN 0.18 mg
Slovenian: PODATKI V BRAILLOVI PISAVI MIRAPEXIN 0,18 mg
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.088 mg tablets Pramipexole
Slovenian: IME ZDRAVILA MIRAPEXIN 0,088 mg tablete pramipeksol
English: MIRAPEXIN 1.57 mg prolonged-release tablets EU/1/97/051/028-030
Slovenian: MIRAPEXIN 1,57 mg tablete s podaljšanim sproščanjem EU/1/97/051/028-030
English: In the absence of human data, MIRAPEXIN should not be used during breast-feeding.
Slovenian: Če je mogoče, zdravila MIRAPEXIN med dojenjem ne dajemo, ker ni podatkov za človeka.
English: - If you get any of the side effects, talk to your doctor or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: The use of MIRAPEXIN has not been studied in haemodialysis patients, or in patients with severe renal impairment.
Slovenian: Pri bolnikih na hemodializi ali s hudo ledvično okvaro uporabe zdravila MIRAPEXIN niso raziskovali.
English: INFORMATION IN BRAILLE MIRAPEXIN 1.57 mg prolonged-release tablets
Slovenian: PODATKI V BRAILLOVI PISAVI MIRAPEXIN 1,57 mg tablete s podaljšanim sproščanjem
English: INFORMATION IN BRAILLE MIRAPEXIN 0.7 mg
Slovenian: PODATKI V BRAILLOVI PISAVI MIRAPEXIN 0,7 mg
English: 1 tablet MIRAPEXIN 0.18 mg
Slovenian: 1 tableta zdravila MIRAPEXIN po 0,18 mg
English: 1 tablet MIRAPEXIN 0.18 mg three times a day OR
Slovenian: 1 tableta zdravila MIRAPEXIN po 0,18 mg 3-krat na dan
English: 1 tablet MIRAPEXIN 0.088 mg
Slovenian: 1 tableta zdravila MIRAPEXIN po 0,088 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/011 [30 tablets]
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/97/051/011 [30 tablet]
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.35 mg tablets Pramipexole
Slovenian: IME ZDRAVILA MIRAPEXIN 0,35 mg tablete pramipeksol
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.18 mg tablets Pramipexole
Slovenian: IME ZDRAVILA MIRAPEXIN 0,18 mg tablete pramipeksol
English: EU/1/97/051/004 [100 tablets]
Slovenian: EU/1/97/051/004 [100 tablet]
English: Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg pramipexole.
Slovenian: Ena tableta vsebuje 0,088 mg pramipeksola v obliki 0,125 mg pramipeksolijevega diklorida monohidrata.
English: C.
Slovenian: SN:
English: MIRAPEXIN 1.57 mg prolonged-release tablets
Slovenian: MIRAPEXIN 1,57 mg tablete s podaljšanim sproščanjem pramipeksol
English: Each prolonged-release tablet contains 3 mg pramipexole dihydrochloride monohydrate equivalent to 2.1 mg pramipexole.
Slovenian: Ena tableta s podaljšanim sproščanjem vsebuje 2,1 mg pramipeksola v obliki 3 mg pramipeksolijevega diklorida monohidrata.
English: Each prolonged-release tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.05 mg pramipexole.
Slovenian: MIRAPEXIN 1,05 mg tablete s podaljšanim sproščanjem Ena tableta s podaljšanim sproščanjem vsebuje 1,05 mg pramipeksola v obliki 1,5 mg pramipeksolijevega diklorida monohidrata.
English: Only one patient switched to MIRAPEXIN prolonged-release tablets experienced a drug-related adverse event leading to withdrawal.
Slovenian: Z zdravilom povezan neželeni dogodek, zaradi katerega je bilo zdravljenje ukinjeno, je imel po prehodu na MIRAPEXIN tablete s podaljšanim sproščanjem samo en bolnik.
English: INFORMATION IN BRAILLE MIRAPEXIN 2.1 mg prolonged-release tablets
Slovenian: PODATKI V BRAILLOVI PISAVI MIRAPEXIN 2,1 mg tablete s podaljšanim sproščanjem
English: MIRAPEXIN 2.1 mg prolonged-release tablets
Slovenian: MIRAPEXIN 2,1 mg tablete s podaljšanim sproščanjem pramipeksol
English: How to store MIRAPEXIN
Slovenian: Shranjevanje zdravila MIRAPEXIN
English: Prolonged-release tablet
Slovenian: FARMACEVTSKA OBLIKA tableta s podaljšanim sproščanjem
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]
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/97/051/016 [10 tablet s podaljšanim sproščanjem] EU/1/97/051/017 [30 tablet s podaljšanim sproščanjem] EU/1/97/051/018 [100 tablet s podaljšanim sproščanjem]
English: EU/1/97/051/002 [100 tablets]
Slovenian: EU/1/97/051/002 [100 tablet]
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).
Slovenian: Tablete so bele, ploščate, okrogle in imajo vtisnjeno oznako (na eni strani je oznaka P6, na drugi pa znak podjetja Boehringer Ingelheim).
English: 1 tablet MIRAPEXIN 0.35 mg and 1 tablet MIRAPEXIN 0.18 mg OR
Slovenian: 1 tableta zdravila MIRAPEXIN po 0,35 mg ALI 2 tableti zdravila MIRAPEXIN po 0,18 mg ALI 4 tablete zdravila MIRAPEXIN po 0,088 mg
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.7 mg tablets Pramipexole
Slovenian: IME ZDRAVILA MIRAPEXIN 0,7 mg tablete pramipeksol
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).
Slovenian: Tablete so bele, ploščate, okrogle, z zarezo na obeh straneh in imajo vtisnjeno oznako (na eni strani je oznaka P9, na drugi pa znak podjetja Boehringer Ingelheim).
English: EU/1/97/051/006 [100 tablets]
Slovenian: EU/1/97/051/006 [100 tablet]
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).
Slovenian: Tablete so bele, ploščate, ovalne, z zarezo na obeh straneh in imajo vtisnjeno oznako (na eni strani je oznaka P8, na drugi pa znak podjetja Boehringer Ingelheim).
English: In patients with a creatinine clearance between 20 and 50 ml/min, the initial daily dose of MIRAPEXIN should be administered in two divided doses, starting at 0.088 mg of base (0.125 mg of salt) twice a day (0.176 mg of base/0.25 mg of salt daily).
Slovenian: Začnemo z dajanjem 0,088 mg pramipeksola (0,125 mg soli) dvakrat dnevno (0,176 mg pramipeksola/0,25 mg soli na dan).
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]
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/97/051/025 [10 tablet s podaljšanim sproščanjem] EU/1/97/051/026 [30 tablet s podaljšanim sproščanjem] EU/1/97/051/027 [100 tablet s podaljšanim sproščanjem]
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]
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/97/051/031 [10 tablet s podaljšanim sproščanjem] EU/1/97/051/032 [30 tablet s podaljšanim sproščanjem] EU/1/97/051/033 [100 tablet s podaljšanim sproščanjem]
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]
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/97/051/013 [10 tablet s podaljšanim sproščanjem] EU/1/97/051/014 [30 tablet s podaljšanim sproščanjem] EU/1/97/051/015 [100 tablet s podaljšanim sproščanjem]
English: Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly with MIRAPEXIN.
Slovenian: Kadar dajemo navedena zdravila sočasno z zdravilom MIRAPEXIN, moramo upoštevati zmanjšanje odmerka pramipeksola.
English: Hepatic impairment
Slovenian: Sindrom nemirnih nog
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]
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/97/051/028 [10 tablet s podaljšanim sproščanjem] EU/1/97/051/029 [30 tablet s podaljšanim sproščanjem] EU/1/97/051/030 [100 tablet s podaljšanim sproščanjem]
English: MARKETING AUTHORISATION NUMBER(S) MIRAPEXIN 0.26 mg prolonged-release tablets EU/1/97/051/013-015
Slovenian: MIRAPEXIN 0,26 mg tablete s podaljšanim sproščanjem EU/1/97/051/013-015
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).
Slovenian: Tablete so bele, ploščate, ovalne, z zarezo na obeh straneh in imajo vtisnjeno oznako (na eni strani je oznaka P7, na drugi pa znak podjetja Boehringer Ingelheim).
English: Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg pramipexole.
Slovenian: Ena tableta vsebuje 0,18 mg pramipeksola v obliki 0,25 mg pramipeksolijevega diklorida monohidrata.
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]
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/97/051/022 [10 tablet s podaljšanim sproščanjem] EU/1/97/051/023 [30 tablet s podaljšanim sproščanjem] EU/1/97/051/024 [100 tablet s podaljšanim sproščanjem]
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/005 [30 tablets]
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/97/051/005 [30 tablet]
English: Colloidal anhydrous silica Magnesium stearate
Slovenian: 6.1 Seznam pomožnih snovi manitol koruzni škrob brezvodni koloidni silicijev dioksid povidon K 25 magnezijev stearat
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]
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/97/051/019 [10 tablet s podaljšanim sproščanjem] EU/1/97/051/020 [30 tablet s podaljšanim sproščanjem] EU/1/97/051/021 [100 tablet s podaljšanim sproščanjem]
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/003 [30 tablets]
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/97/051/003 [30 tablet]
English: MIRAPEXIN is used to: - treat the symptoms of primary Parkinson's disease in adults.
Slovenian: Zdravilo MIRAPEXIN uporabljamo za: - zdravljenje simptomov primarne Parkinsonove bolezni pri odraslih; lahko ga uporabljamo samostojno ali v kombinaciji z levodopo (drugo zdravilo za Parkinsonovo bolezen); - zdravljenje simptomov zmernega do hudega primarnega sindroma nemirnih nog pri odraslih.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/001 [30 tablets]
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/97/051/001 [30 tablet]
English: Each prolonged-release tablet contains 4.5 mg pramipexole dihydrochloride monohydrate equivalent to 3.15 mg pramipexole.
Slovenian: MIRAPEXIN 3,15 mg tablete s podaljšanim sproščanjem Ena tableta s podaljšanim sproščanjem vsebuje 3,15 mg pramipeksola v obliki 4,5 mg pramipeksolijevega diklorida monohidrata.
English: Each prolonged-release tablet contains 3.75 mg pramipexole dihydrochloride monohydrate equivalent to 2.62 mg pramipexole.
Slovenian: MIRAPEXIN 2,62 mg tablete s podaljšanim sproščanjem Ena tableta s podaljšanim sproščanjem vsebuje 2,62 mg pramipeksola v obliki 3,75 mg pramipeksolijevega diklorida monohidrata.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.26 mg pramipexole.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta s podaljšanim sproščanjem vsebuje 0,26 mg pramipeksola v obliki 0,375 mg pramipeksolijevega diklorida monohidrata.
English: - Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs).
Slovenian: - Diskinezija (na primer nenormalni, nenadzorovani gibi udov): Če imate napredovalo
English: Each prolonged-release tablet contains 2.25 mg pramipexole dihydrochloride monohydrate equivalent to 1.57 mg pramipexole.
Slovenian: MIRAPEXIN 1,57 mg tablete s podaljšanim sproščanjem Ena tableta s podaljšanim sproščanjem vsebuje 1,57 mg pramipeksola v obliki 2,25 mg pramipeksolijevega diklorida monohidrata.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg pramipexole.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 0,7 mg pramipeksola v obliki 1,0 mg pramipeksolijevega diklorida monohidrata.
English: Each prolonged-release tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.52 mg pramipexole.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta s podaljšanim sproščanjem vsebuje 0,52 mg pramipeksola v obliki 0,75 mg pramipeksolijevega diklorida monohidrata.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.35 mg pramipexole.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 0,35 mg pramipeksola v obliki 0,5 mg pramipeksolijevega diklorida monohidrata.
English: Superiority of MIRAPEXIN prolonged-release tablets over placebo was demonstrated after 18 weeks of treatment on both the primary (UPDRS Parts II+III score) and the key secondary (CGI-I and PGI-I responder rates) efficacy endpoints in a double-blind placebo-controlled trial including a total of 539 patients with early Parkinson's disease.
Slovenian: To je pokazalo dvojno slepo, s placebom nadzorovano preskušanje, ki je skupno zajela 539 bolnikov z zgodnjo Parkinsonovo boleznijo, ko so po 18 tednih jemanja z dvema lestvicama ocenili primarne (lestvica UPDRS, ocena II.
English: two MIRAPEXIN 0.52 mg prolonged-release tablets, OR four MIRAPEXIN 0.26 mg prolonged-release tablets.
Slovenian: Število tablet ena MIRAPEXIN 0,26 mg tableta s podaljšanim sproščanjem ena MIRAPEXIN 0,52 mg tableta s podaljšanim sproščanjem ALI dve MIRAPEXIN 0,26 mg tableti s podaljšanim sproščanjem ena MIRAPEXIN 1,05 mg tableta s podaljšanim sproščanjem ALI dve MIRAPEXIN 0,52 mg tableti s podaljšanim sproščanjem ALI štiri MIRAPEXIN 0,26 mg tablete s podaljšanim sproščanjem
English: Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.35 mg pramipexole.
Slovenian: MIRAPEXIN 0,35 mg tablete Ena tableta vsebuje 0,35 mg pramipeksola v obliki 0,5 mg pramipeksolijevega diklorida monohidrata.
English: Warnings and precautions Talk to your doctor before taking MIRAPEXIN.
Slovenian: Pred začetkom jemanja zdravila MIRAPEXIN se posvetujte s svojim zdravnikom.
English: 40 (1 cartridge x 40) tablets
Slovenian: 40 (1 vložek x 40) tablet
English: Immediate Packaging Pack size
Slovenian: Jakost Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja
English: EU number
Slovenian: Številka EU Ime
English: Name
Slovenian: Ovojnina
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Slovenian: Številka (EU) dovoljenja za promet
English: All indications are not authorised in all EU MS.
Slovenian: Vse indikacije niso odobrene v vseh državah članicah EU.
English: The CMDh position was forwarded to the European Commission.
Slovenian: Stališče skupine CMDh je bilo posredovano Evropski komisiji.
English: 2 - CMDh revised position
Slovenian: 2 - Revidirano stališče skupine CMDh
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.
Slovenian: Odbor PRAC je ugotovil, da je ocena globalne izpostavljenosti samo zdravilom originatorjem več kot 50 milijonov bolnikovih let, v zadnjem desetletju v EU pa približno 6,8 milijona bolnikovih let.
English: Further, the definition of the relevant clinical endpoints and the measurement of symptoms in these conditions are challenging (Rubin, 2007).
Slovenian: Poleg tega sta opredelitev zadevnih kliničnih opazovanih dogodkov in meritev simptomov teh stanj težavna (Rubin, 2007).
English: These constitute the majority of the available evidence, in particular in the indications that were first authorised (e.g. secretolytic indication).
Slovenian: Te študije sestavljajo večino razpoložljivih dokazov, zlasti pri indikacijah, ki so bile odobrene na začetku (npr. sekretolitična indikacija).
English: The level of evidence did not allow for further stratification by age group.
Slovenian: Stopnja dokazov ni omogočala nadaljnje stratifikacije po starostnih skupinah.
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.
Slovenian: To ni nepričakovano glede na metodološke izzive, povezane s tem terapevtskim področjem, in dokazne standarde ter zahteve v času prvega razvoja teh zdravil.
English: The PDCO was also of the view that these products are no longer the preferred treatment option in IRDS.
Slovenian: Komisija PDCO je prav tako menila, da ta zdravila niso več prednostna možnost pri zdravljenju IRDS.
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.
Slovenian: Treba je omeniti, da zdravila, ki se uvedejo manj kot 4 dni ali več kot 8 tednov pred začetkom reakcije, niso verjetni povzročitelji.
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.
Slovenian: Na podlagi kliničnih izkušenj je komisija PDCO menila, da ni potrebe po uporabi teh zdravil za to indikacijo pri otrocih, mlajših od dveh let.
English: However, prompt recognition of severe reactions and early withdrawal of the causative agent is the most important factor to minimise morbidity and mortality.
Slovenian: Vendar sta takojšnje prepoznavanje hudih reakcij in zgodnja prekinitev jemanja povzročitelja najpomembnejša dejavnika pri zmanjševanju obolevnosti in umrljivosti.
English: The PRAC also considered the available data in the paediatric population.
Slovenian: Odbor PRAC je prav tako upošteval razpoložljive podatke pri pediatrični populaciji.
English: 1 - Overall summary of the scientific evaluation by the PRAC Safety issues
Slovenian: 1 - Splošni povzetek znanstvenega vrednotenja odbora PRAC
English: It is acknowledged that most of the indications are supported by old studies presenting limitations and deficiencies.
Slovenian: Prav tako je upošteval, da je večina indikacij podprta s starimi študijami, kar pomeni omejitve in pomanjkljivosti.
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.
Slovenian: Med odločanjem na sestanku Stalnega odbora za zdravila za uporabo v humani medicini so nekatere države članice sprožile nova vprašanja tehnične narave, za katere so menile, da v priporočilu odbora PRAC in stališču skupine CMDh niso bila obravnavana v zadostni meri.
English: Most often these patients receive a number of drugs concomitantly and causality assessment is difficult.
Slovenian: Najpogosteje ti bolniki prejmejo številna sočasna zdravila, zato je ocena vzročnosti težavna.
English: In light of this, the PRAC recommendation and CMDh position was referred back to the Agency for further consideration.
Slovenian: Na podlagi zgoraj navedenega sta bila priporočilo odbora PRAC in stališče skupine CMDh vrnjena Agenciji v ponovno preučitev.
English: It is recognised also that the limitations and uncertainties attached to the dataset hinder the ability to draw robust conclusions on the efficacy.
Slovenian: Znano je tudi, da omejitve in negotovosti, povezane z naborom podatkom, ovirajo pripravo grobih zaključkov o učinkovitosti.
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.
Slovenian: Zdravila, ki vsebujejo ambroksol in bromheksin, so bila v državi članici Evropske unije prvič odobrena leta 1978 oziroma 1963, trenutno pa so odobrena v vseh državah članicah EU (vključno z Norveško in Islandijo), razen v Združenem kraljestvu.
English: However, the overall reporting rate is very low when the estimated exposure is considered and many confounders are present in these cases, the evidence supporting this risk is therefore weak.
Slovenian: Vendar je splošni delež poročanja zelo majhen, če se upošteva ocena izpostavljenosti in obstaja prisotnost mnogih zavajajočih dejavnikov v teh primerih, zato so dokazi, ki podpirajo to tveganje, šibki.
English: Many drug reactions cannot be distinguished from naturally occurring or infection-induced eruptions, and thus misdiagnosis is common.
Slovenian: Mnogih reakcij na zdravila ni mogoče razlikovati od naravnih reakcij ali izbruhov, ki jih povzroča okužba, zato je napačna diagnoza pogosta.
English: Consequently the PSUR cycle should be shortened to a 3-yearly cycle in order to periodically review these analyses.
Slovenian: Posledično je treba cikel za predložitev poročila PSUR skrajšati na trikrat na leto, da bo mogoče pogosto pregledovati te analize.
English: Moreover SCARs cases should be analysed in details in future PSURs.
Slovenian: Poleg tega je treba primere SCAR v prihodnjih poročilih PSUR podrobno analizirati.
English: However, a shorter PSUR cycle should be introduced to continue to review periodically data that becomes available on the benefit-risk balance of the products.
Slovenian: Vendar pa je treba vpeljati krajši cikel za predložitev poročila PSUR, da se bodo še naprej redno pregledovali razpoložljivi podatki o razmerju med tveganji in koristmi zdravil.