natgillin/translations-raw huggingface dataset:
Tritace 2.5 mg таблетки, Tritace 5 mg таблетки, Tritace 10 mg таблетки
Tritace 2. 5 mg таблетки, Tritace 5 mg таблетки, Tritace 10 mg таблетки
Triatec 2.5 mg δισκία, Triatec 5 mg δισκία, Triatec 10 mg δισκία
Triatec 2. 5 mg δισκία, Triatec 5 mg δισκία, Triatec 10 mg δισκία
Tritace 1.25 mg tablety, Tritace 2.5 mg tablety, Tritace 5 mg tablety, Tritace 10 mg tablety Ramipril Winthrop 1.25 mg tobolky, Ramipril Winthrop 2.5 mg tobolky, Ramipril Winthrop 5 mg tobolky,
Tritace 1. 25 mg tablety, Tritace 2. 5 mg tablety, Tritace 5 mg tablety, Tritace 10 mg tablety Ramipril Winthrop 1. 25 mg tobolky, Ramipril Winthrop 2. 5 mg tobolky, Ramipril Winthrop 5 mg tobolky,
Triatec 1.25 mg tabletter, Triatec 2.5 mg tabletter, Triatec 5 mg tabletter, Triatec 10 mg kapsler
Triatec 1. 25 mg tabletter, Triatec 2. 5 mg tabletter, Triatec 5 mg tabletter, Triatec 10 mg kapsler
Cardace 2.5 mg tabletid, Cardace 5 mg tabletid, Cardace 10 mg tabletid
Cardace 2. 5 mg tabletid, Cardace 5 mg tabletid, Cardace 10 mg tabletid
Cardace 1.25 mg tabletit, Cardace 2.5 mg tabletit, Cardace 5 mg tabletit, Cardace 10 mg tabletit, Cardace 10 mg kapselit Ramipril Medgenerics 1.25 mg tabletit, Ramipril Medgenerics 2.5 mg tabletit, Ramipril Medgenerics 5 mg tabletit, Ramipril Medgenerics 10 mg tabletit
Cardace 1. 25 mg tabletit, Cardace 2. 5 mg tabletit, Cardace 5 mg tabletit, Cardace 10 mg tabletit, Cardace 10 mg kapselit Ramipril Medgenerics 1. 25 mg tabletit, Ramipril Medgenerics 2. 5 mg tabletit, Ramipril Medgenerics 5 mg tabletit, Ramipril Medgenerics 10 mg tabletit
Triatec 1.25 mg comprimés, Triatec 2.5 mg comprimés, Triatec 5 mg comprimés, Triatec 10 mg comprimés Triateckit 2.5 mg comprimés, Triateckit 5 mg comprimés, Triateckit 10 mg comprimés Ramikit 2.5 mg comprimés, Ramikit 5 mg comprimés, Ramikit 10 mg comprimés Triatec faible 1.25 mg gélules Triatec 2.5 mg gélules, Triatec 5 mg gélules Ramipril Winthrop 1.25 mg comprimés, Ramipril Winthrop 2.5 mg comprimés, Ramipril Winthrop 5 mg comprimés, Ramipril Winthrop 10 mg comprimés
Triatec 1. 25 mg comprimés, Triatec 2. 5 mg comprimés, Triatec 5 mg comprimés, Triatec 10 mg comprimés Triateckit 2. 5 mg comprimés, Triateckit 5 mg comprimés, Triateckit 10 mg comprimés Ramikit 2. 5 mg comprimés, Ramikit 5 mg comprimés, Ramikit 10 mg comprimés Triatec faible 1. 25 mg gélules Triatec 2. 5 mg gélules, Triatec 5 mg gélules Ramipril Winthrop 1. 25 mg comprimés, Ramipril Winthrop 2. 5 mg comprimés, Ramipril Winthrop 5 mg comprimés, Ramipril Winthrop 10 mg comprimés
Delix 2.5 mg Tabletten, Delix 5 mg Tabletten, Delix 10 mg Tabletten Delix Protect Startset Ramilich 2.5 mg Tabletten, Ramilich 5 mg Tabletten, Ramilich 10 mg Tabletten Ramilich Startset Delix 1.25 mg Tabletten, Delix 1.25 mg Kapseln, Delix 2.5 mg Kapseln, Delix 5 mg Kapseln, Delix 10 mg Kapseln Vesdil 1.25 mg Kapseln, Vesdil 2.5 mg Kapseln, Vesdil 5 mg Kapseln, Vesdil 1.25 mg Tabletten, Vesdil 2.5 mg Tabletten
Delix 2. 5 mg Tabletten, Delix 5 mg Tabletten, Delix 10 mg Tabletten Delix Protect Startset Ramilich 2. 5 mg Tabletten, Ramilich 5 mg Tabletten, Ramilich 10 mg Tabletten Ramilich Startset Delix 1. 25 mg Tabletten, Delix 1. 25 mg Kapseln, Delix 2. 5 mg Kapseln, Delix 5 mg Kapseln, Delix 10 mg Kapseln Vesdil 1. 25 mg Kapseln, Vesdil 2. 5 mg Kapseln, Vesdil 5 mg Kapseln, Vesdil 1. 25 mg Tabletten, Vesdil 2. 5 mg Tabletten Vesdil N 2. 5 mg Tabletten, Vesdil N 5 mg Tabletten Vedil 5 mg Tabletten Vesdil Protect 10 mg Tabletten
Triatec 1.25 mg δισκία, Triatec 2.5 mg δισκία, Triatec 5 mg δισκία
Triatec 1. 25 mg δισκία, Triatec 2. 5 mg δισκία, Triatec 5 mg δισκία
Hungary:
44 Ungari:
Tritace Mite 1.25 mg tabletta Tritace 2.5 mg tabletta, Tritace 5 mg tabletta, Tritace 10 mg tabletta Ramipril Prevent 1.25 mg tabletta, Ramipril Prevent 2.5 mg tabletta, Ramipril Prevent 5 mg tabletta, Ramipril Prevent 10 mg tabletta Ramiwin 1.25 mg tabletta, Ramiwin 2.5 mg tabletta, Ramiwin 5 mg tabletta, Ramiwin 10 mg tabletta
Tritace Mite 1. 25 mg tabletta Tritace 2. 5 mg tabletta, Tritace 5 mg tabletta, Tritace 10 mg tabletta Ramipril Prevent 1. 25 mg tabletta, Ramipril Prevent 2. 5 mg tabletta, Ramipril Prevent 5 mg tabletta, Ramipril Prevent 10 mg tabletta Ramiwin 1. 25 mg tabletta, Ramiwin 2. 5 mg tabletta, Ramiwin 5 mg tabletta, Ramiwin 10 mg tabletta
Tritace 1.25 mg tablets, Tritace 2.5 mg tablets, Tritace 5 mg tablets, Tritace 10 mg tablets, Tritace 1.25 mg capsules, Tritace 2.5 mg capsules, Tritace 5 mg capsules, Tritace 10 mg capsules Loavel 1.25 mg tablets, Loavel 2.5 mg tablets, Loavel 5 mg tablets, Loavel 10 mg tablets, Loavel 1.25 mg capsules, Loavel 2.5 mg capsules, Loavel 5 mg capsules, Loavel 10 mg capsules Ramipril 1.25 mg tablets, Ramipril 2.5 mg tablets, Ramipril 5 mg tablets, Ramipril 10 mg tablets, Ramipril 1.25 mg capsules, Ramipril 2.5 mg capsules, Ramipril 5 mg capsules, Ramipril 10 mg capsules
Tritace 1. 25 mg tablets, Tritace 2. 5 mg tablets, Tritace 5 mg tablets, Tritace 10 mg tablets, Tritace 1. 25 mg capsules, Tritace 2. 5 mg capsules, Tritace 5 mg capsules, Tritace 10 mg capsules Loavel 1. 25 mg tablets, Loavel 2. 5 mg tablets, Loavel 5 mg tablets, Loavel 10 mg tablets, Loavel 1. 25 mg capsules, Loavel 2. 5 mg capsules, Loavel 5 mg capsules, Loavel 10 mg capsules Ramipril 1. 25 mg tablets, Ramipril 2. 5 mg tablets, Ramipril 5 mg tablets, Ramipril 10 mg tablets, Ramipril 1. 25 mg capsules, Ramipril 2. 5 mg capsules, Ramipril 5 mg capsules, Ramipril 10 mg capsules
Triatec 1.25 mg compresse, Triatec 2.5 mg compresse, Triatec 5 mg compresse, Triatec 10 mg compresse Ramipril sanofi-aventis 2.5 mg compresse, Ramipril sanofi-aventis 5 mg compresse, Ramipril sanofi-aventis 10 mg compresse Unipril 1.25 mg compresse, Unipril 2.5 mg compresse, Unipril 5 mg compresse, Unipril 10 mg compresse Quark 1.25 mg compresse, Quark 2.5 mg compresse, Quark 5 mg compresse, Quark 10 mg compresse
Triatec 1. 25 mg compresse, Triatec 2. 5 mg compresse, Triatec 5 mg compresse, Triatec 10 mg compresse Ramipril sanofi- aventis 2. 5 mg compresse, Ramipril sanofi- aventis 5 mg compresse, Ramipril sanofi - aventis 10 mg compresse Unipril 1. 25 mg compresse, Unipril 2. 5 mg compresse, Unipril 5 mg compresse, Unipril 10 mg compresse Quark 1. 25 mg compresse, Quark 2. 5 mg compresse, Quark 5 mg compresse, Quark 10 mg compresse
Cardace 2.5 mg tabletes, Cardace 5 mg tabletes, Cardace 10 mg tabletes
Cardace 2. 5 mg tabletes, Cardace 5 mg tabletes, Cardace 10 mg tabletes
Cardace 2.5 mg tabletė s, Cardace 5 mg tabletė s, Cardace 10 mg tabletė s
Cardace 2. 5 mg tabletės, Cardace 5 mg tabletės, Cardace 10 mg tabletės
Tritace 1.25 mg tabletten, Tritace 2.5 mg tabletten, Tritace 5 mg tabletten, Tritace 10 mg tabletten, Tritace 1.25 mg capsules, Tritace 2.5 mg capsules, Tritace 5 mg capsules, Tritace 10 mg capsules
Tritace 1. 25 mg tabletten, Tritace 2. 5 mg tabletten, Tritace 5 mg tabletten, Tritace 10 mg tabletten, Tritace 1. 25 mg capsules, Tritace 2. 5 mg capsules, Tritace 5 mg capsules, Tritace 10 mg capsules
Triatec 1.25 mg tabletter, Triatec 2.5 mg tabletter, Triatec 5 mg tabletter, Triatec 10 mg tabletter, Triatec 10 mg capsules, Ramipril Winthrop 1.25 mg tabletter, Ramipril Winthrop 2.5 mg tabletter, Ramipril Winthrop 5 mg tabletter, Ramipril Winthrop 10 mg tabletter
Triatec 1. 25 mg tabletter, Triatec 2. 5 mg tabletter, Triatec 5 mg tabletter, Triatec 10 mg tabletter, Triatec 10 mg capsules, Ramipril Winthrop 1. 25 mg tabletter, Ramipril Winthrop 2. 5 mg tabletter, Ramipril Winthrop 5 mg tabletter, Ramipril Winthrop 10 mg tabletter
47 Tritace 2.5 mg tabletki, Tritace 5 mg tabletki, Tritace 10 mg tabletki
Tritace 2. 5 mg tabletki, Tritace 5 mg tabletki, Tritace 10 mg tabletki
Triatec 1.25 mg comprimidos, Triatec 2.5 mg comprimidos, Triatec 5 mg comprimidos, Triatec 10 mg comprimidos, Triatec 1.25 mg cápsulas, Triatec 2.5 mg cápsulas, Triatec 5 mg cápsulas, Triatec 10 mg cápsulas
Triatec 1. 25 mg comprimidos, Triatec 2. 5 mg comprimidos, Triatec 5 mg comprimidos, Triatec 10 mg comprimidos, Triatec 1. 25 mg cápsulas, Triatec 2. 5 mg cápsulas, Triatec 5 mg cápsulas, Triatec 10 mg cápsulas
Tritace 2.5 mg comprimate, Tritace 5 mg comprimate, Tritace 10 mg comprimate Zenra 2.5 mg comprimate, Zenra 5 mg comprimate, Zenra 10 mg comprimate
45 Tritace 2. 5 mg comprimate, Tritace 5 mg comprimate, Tritace 10 mg comprimate Zenra 2. 5 mg comprimate, Zenra 5 mg comprimate, Zenra 10 mg comprimate
Tritace 1.25 mg tablety, Tritace 2.5 mg tablety, Tritace 5 mg tablety, Tritace 10 mg tablety
Tritace 1. 25 mg tablety, Tritace 2. 5 mg tablety, Tritace 5 mg tablety, Tritace 10 mg tablety
Tritace 1.25 mg tablete, Tritace 2.5 mg tablete, Tritace 5 mg tablete, Tritace 10 mg tablete
Tritace 1. 25 mg tablete, Tritace 2. 5 mg tablete, Tritace 5 mg tablete, Tritace 10 mg tablete
Acovil 1.25 mg comprimidos, Acovil 2.5 mg comprimidos, Acovil 5 mg comprimidos, Acovil 10 mg comprimidos
Acovil 1. 25 mg comprimidos, Acovil 2. 5 mg comprimidos, Acovil 5 mg comprimidos, Acovil 10 mg comprimidos
Triatec 1.25 mg tabletter, Triatec 2.5 mg tabletter, Triatec 5 mg tabletter, Triatec 10 mg tabletter, Triatec Hope tabletter Triatec start tabletter Ramipril Winthrop 1.25 mg tabletter, Ramipril Winthrop 2.5 mg tabletter, Ramipril Winthrop 5 mg tabletter, Ramipril Winthrop 10 mg tabletter Pramace 1.25 mg tabletter, Pramace 2.5 mg tabletter, Pramace 5 mg tabletter, Pramace 10 mg tabletter, Pramace 10 mg kapslar
Triatec 1. 25 mg tabletter, Triatec 2. 5 mg tabletter, Triatec 5 mg tabletter, Triatec 10 mg tabletter, Triatec Hope tabletter Triatec start tabletter Ramipril Winthrop 1. 25 mg tabletter, Ramipril Winthrop 2. 5 mg tabletter, Ramipril Winthrop 5 mg tabletter, Ramipril Winthrop 10 mg tabletter Pramace 1. 25 mg tabletter, Pramace 2. 5 mg tabletter, Pramace 5 mg tabletter, Pramace 10 mg tabletter, Pramace 10 mg kapslar
United Kingdom Tritace 1.25 mg tablets, Tritace 2.5 mg tablets, Tritace 5 mg tablets, Tritace 10 mg tablets, Tritace 1.25 mg capsules, Tritace 2.5 mg capsules, Tritace 5 mg capsules, Tritace 10 mg capsules Tritace Titration Pack capsules, Tritace Titration Pack tablets
Ühendkuningriik Tritace 1. 25 mg tablets, Tritace 2. 5 mg tablets, Tritace 5 mg tablets, Tritace 10 mg tablets, Tritace 1. 25 mg capsules, Tritace 2. 5 mg capsules, Tritace 5 mg capsules, Tritace 10 mg capsules Tritace Titration Pack capsules, Tritace Titration Pack tablets
This leaflet was last approved in {MM/ YYYY} [To be completed nationally]
Infoleht on viimati kooskõlastatud {MM/ YYYY} [Täidetakse rahvuslikult]
Ref.
London, 18. märts 2009 Viide:
EMEA/ CHMP/ 233264/ 2009
EMEA/ 202964/ 2009
Questions and answers on the referral for Tritace tablet and hard capsules containing ramipril 1.25 mg, 2.5 mg, 5 mg and 10 mg
Teave esildismenetluse kohta, mis käsitles ravimit Tritace (tabletid ja kõvakapslid, ramipriil 1, 25 mg, 2, 5 mg, 5 mg ja 10 mg)
The Agency’ s Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Tritace in the European Union (EU) and the European Economic Area (EEA).
Inimravimite komitee otsustas, et Euroopa Liidus ja Euroopa Majanduspiirkonnas on vaja ühtlustada Tritace määramisega seotud teave.
The review was carried out under an ‘ Article 30’ referral 1.
Taotlus vaadati läbi artikli 30 kohase esildismenetluse 1 korras.
Tritace is also used to prevent cardiovascular disease in patients who are at cardiovascular risk (such as patients who already have coronary artery disease), and to prevent any further heart attack (acute myocardial infarction [MI]) in patients who have already had one.
Tritacet kasutatakse ka kardiovaskulaarhaiguste (südame- veresoonkonna haiguste) tekke riskiga patsientidel (näiteks patsientidel, kellel juba on südameisheemiatõbi) kardiovaskulaarhaiguste ennetamiseks ning järgmise ägeda südamelihaseinfarkti ennetamiseks patsientidel, kellel on üks infarkt juba olnud.
The active substance in Tritace, ramipril, is an angiotensin- converting enzyme (ACE) inhibitor.
Tritace toimeaine ramipriil on angiotensiinkonvertaasi (ACE) inhibiitor.
ACE inhibitors lower the production of angiotensin II, a powerful vasoconstrictor (a substance that narrows blood vessels).
ACE- inhibiitorid vähendavad tugevatoimelise vasokonstriktori (veresooni ahendav aine) angiotensiin II teket organismis, mille tulemusel veresooned lõõgastuvad ja laienevad.
When the production of angiotensin II is lowered, the blood vessels relax and widen.
See võimaldab efektiivsemat südametegevust (vere pumpamist soontes).
Tritace has been authorised in the EU since 1989, first in France and then in the following countries:
Tritace on Euroopa Liidus olnud heaks kiidetud alates 1989. aastast, kõigepealt Prantsusmaal ja seejärel järgmistes riikides:
Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom.
Austria, Belgia, Bulgaaria, Küpros, Tšehhi Vabariik, Taani, Eesti, Soome, Prantsusmaa, Saksamaa, Kreeka, Ungari, Iirimaa, Itaalia, Läti, Leedu, Luksemburg, Madalmaad, Norra, Poola, Portugal, Rumeenia, Slovakkia, Sloveenia, Hispaania, Rootsi ja Ühendkuningriik.
Tritace can also be available in the EU and the EEA under other trade names:
Tritacet võidakse Euroopa Ühenduses ja Euroopa Majanduspiirkonnas turustada ka teiste nimetuste all:
Triatec, Triatec Hope, Cardace, Delix, Delix Protect, Delix Protect Startset, Delix P, Ramipril Winthrop, Ramipril Prevent, Loavel, Ramiwin, Ramipril Medgenerics, Ramilich, Tritace Titration, Acovil, Tritace Mite, Triateckit, Ramikit, Hypren, Ramace, Vesdil, Vesdil Protect, Ramipril-Zentiva, Unipril, Quark, Zenra, Pramace.
Triatec, Triatec Hope, Cardace, Delix, Delix Protect, Delix Protect Startset, Delix P, Ramipril Winthrop, Ramipril Prevent, Loavel, Ramiwin, Ramipril Medgenerics, Ramilich, Tritace Titration, Acovil, Tritace Mite, Triateckit, Ramikit, Hypren, Ramace, Vesdil, Vesdil Protect, Ramipril- Zentiva, Unipril, Quark, Zenra, Pramace.
The company that markets it is Sanofi-aventis
Tritacet turustab ettevõte Sanofi- aventis.
Tritace has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures – Human (CMD(h)).
Inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste koordinatsioonirühm nimetas Tritace ühtlustamist vajavaks ravimiks.
What are the conclusions of the CHMP?
4. 1 Näidustused
The areas harmonised include:
• Inimravimite komitee leppis kokku järgmises näidustuses:
• The CHMP agreed on the indication:
Hüpertensiooni ravi. • Südamepuudulikkuse näidustuse kaalumisel võttis inimravimite komitee arvesse teiste ACE - inhibiitorite (enalapriil, perindopriil ja lisinopriil) ühtlustamise menetlusi, ja leppis kokku järgmises näidustuses:
Treatment of hypertension. • When considering the indication in heart failure, the CHMP took into consideration previous harmonisations referrals for other ACE-inhibitors (enalapril, perindopril and lisinopril), and agreed on the indication:
Sümptomaatilise südamepuudulikkuse ravi. • Inimravimite komitee arutas ka kardiovaskulaarhaiguste sekundaarse ennetamise näidustusi ja primaarse ennetuse näidustusi suure riskiga patsientidel ning leppis kokku järgmise ühtlustatud näidustuse:
Treatment of symptomatic heart failure. • The CHMP also discussed the indications in the treatment of cardiovascular secondary prevention, and primary prevention in high-risk patients, and endorsed the harmonised indication:
Kardiovaskulaarhaiguste ennetamine: kardiovaskulaarhaigustesse haigestumuse ja suremuse vähendamine järgmistel patsientidel:
Cardiovascular prevention: reduction cardiovascular morbidity and mortality in patients with: i) manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or ii) diabetes with at least one cardiovascular risk factor. • For the secondary prevention after MI in patients with heart failure, the CHMP endorsed the harmonised indication:
1) väljendunud aterotrombootilise kardiovaskulaarhaigusega patsiendid (südame isheemiatõve, insuldi perifeersete veresoonte haiguse anamneesiga patsiendid) või 2) diabeet (suhkurtõbi) koos vähemalt ühe kardiovaskulaarse riskiteguriga. • Sekundaarse ennetamise kohta südamepuudulikkusega patsientidel pärast südamelihaseinfarkti võttis inimravimite komitee vastu järgmise ühtlustatud näidustuse:
Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase of myocardial infarction in patients with clinical signs of heart failure when started > 48 hours following acute myocardial infarction.
Sekundaarne ennetamine pärast ägedat südamelihaseinfarkti: suremuse vähenemine südamelihase infarkti ägedas faasis südamepuudulikkuse kliiniliste tunnustega patsientidel, kui ravi alustatakse > 48 h pärast ägedat südamelihaseinfarkti.
After discussion the CHMP agreed on including the harmonised indication:
Pärast arutelu nõustus inimravimite komitee lisama järgmise ühtlustatud näidustuse:
Treatment of renal disease • Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria • Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor • Manifest glomerular non-diabetic nephropathy as defined by macroproteinuria ≥ 3g/ day
Neeruhaiguse ravi • Algav diabeetiline glomerulaarne nefropaatia, mis on määratletud mikroalbuminuuria esinemisega • Väljendunud diabeetiline glomerulaarne nefropaatia, mis on määratletud makroproteinuuria esinemisega vähemalt ühe kardiovaskulaarse riskiteguriga patsientidel • Väljendunud mittediabeetiline glomerulaarne nefropaatia, mis on määratletud makroproteinuuria esinemisega ≥ 3 g ööpäevas.
The CHMP discussed the areas where there was a divergence identified in the dose recommendations per indication:
Inimravimite komitee arutas ka valdkondi, kus esines näidustuse soovitusliku annuse erinevusi.
For each indication, the posology is presented as starting dose, titration schedule, maintenance dose and maximum dose.
Iga näidustuse korral esitatakse annustamise kohta algannus, annuse kohandamise kava, säilitusannus ja suurim annus.
The CHMP endorsed six contraindications: • Hypersensitivity to the active substance, to any of the excipients or any other ACE (Angiotensin Converting Enzyme) inhibitors (see section 6.1) • History of angioedema (hereditary, idiopathic or due to previous angioedema with ACE inhibitors or AIIRAs (Angiotensin II Receptor Antagonists)) • Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see section 4.5) • Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney • 2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6) • Ramipril must not be used in patients with hypotensive or haemodynamically unstable states.
Inimravimite komitee kinnitas kuus vastunäidustust: • Ülitundlikkus toimeaine või ravimi mis tahes abiaine või mis tahes muu ACE- inhibiitori suhtes (vt lõik 6. 1). • Anamneesis angioödeem (pärilik, idiopaatiline, ACE- inhibiitorite või angiotensiini II restseptori antagonistide (AIIRA) põhjustatud varasem angioödeem). • Ekstrakorporaalne ravi, mille tõttu puutub veri kokku negatiivselt laetud pindadega (vt lõik 4. 5). • Oluline kahepoolne või ainsa funktsioneeriva neeru neeruarteristenoos. • Raseduse teine ja kolmas trimester (vt lõigud 4. 4 ja 4. 6). • Ramipriili ei tohi kasutada hüpotensiooniga või hemodünaamiliselt ebastabiilsetel patsientidel.
The CHMP agreed adding a seventh contraindication:
Komitee nõustus lisama seitsmenda vastunäidustuse:
Ramipril must not be used in patients in patients with hypotensive or haemodynamically unstable states
Ramipriili ei tohi kasutada hüpotensiooniga või hemodünaamiliselt ebastabiilsetel patsientidel.
The CHMP decided to include under this section the harmonised wording:
Välja arvatud juhul, kui ACE -
Unless continued ACE inhibitor/ AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti- hypertensive treatments which have an established safety profile for use in pregnancy.
Lk 2/ 3 • Ägeda südamelihaseinfarkti järgset hüpotensiooni ja neerude düsfunktsiooni esines AIRE uuringu sihtrühmas ramipriili korral sagedamini kui platseebo korral, mille tõttu otsustas inimravimite komitee lisada järgmise sõnastuse: mööduv või püsiv südamepuudulikkus pärast südamelihaseinfarkti. • Operatsioon.
It is recommended that treatment with angiotensin converting enzyme inhibitors such as ramipril should be discontinued where possible one day before surgery. • Hyperkalaemia • Neutropenia/ agranulocytosis • Cough
Ravi angiotensiinkonvertaasi (ACE) inhibiitoritega, näiteks ramipriiliga, on soovitatav katkestada üks päev enne operatsiooni, kui see on võimalik. • Hüperkaleemia • Neutropeenia / agranulotsütoos • Köha
This is in line with the recommendation of the CHMP’ s Pharmacovigilance Working Party on the use of ACE inhibitors in pregnancy.
See on kooskõlas inimravimite komitee ravimiohutuse järelevalve töörühma soovitustega ACE - inhibiitorite kasutamise kohta raseduse ajal.
Dr Ian Hudson (UK) Prof János Borvendég (HU) 24 January 2008 28 April 2008, 24 October 2008 18 December 2008
dr Ian Hudson (Ühendkuningriik) prof János Borvendég (Ungari) 24. jaanuar 2008 28. aprill 2008, 24. oktoober 2008 18. detsember 2008
Page 3/ 3
Lk 3/ 3
SANOFI-AVENTIS GMBH OSTERREICH
SANOFI- AVENTIS GMBH
Tritazide 25 mg/ 125 mg Tabletten
Tritazide 25 mg/ 125 mg
2,5 mg / 12,5 mg
2, 5 mg / 12, 5 mg
SATURN Tower Leonard-Bernstein-Straße 10 A-1220 Vienna Austria
OSTERREICH SATURN Tower Leonard- Bernstein- Straße 10 A- 1220 Vienna Austria
Tritazide 5 mg/ 25 mg Tabletten 5 mg/ 25mg
Tritazide 5 mg/ 25 mg Tablettten
HYPREN PLUS 2.5 mg / 12.5mg
HYPREN PLUS
A-1037 Wien Austria
A- 1037 Wien Austria
HYPREN PLUS FORTE 5 mg/ 25mg
5 mg/ 25mg
Sanofi-aventis Belgium Culliganlaan 1C 1831 Diegem Belgium
Sanofi- aventis Belgium Culliganlaan 1C 1831 Diegem Belgia
TRITAZIDE 5 mg – 25 mg, 5mg / 25mg tabletten
TRITAZIDE 5 mg – 25 mg, Tablettten
AVENTIS PHARMA DEUTSCHLAND GMBH D-65926 Frankfurt am Main, Germany
AVENTIS PHARMA DEUTSCHLAND GMBH D- 65926 Frankfurt am Main, Saksamaa
TRITACE 2.5 PLUS 2.5 mg / 12.5mg
TRITACE 2. 5 PLUS
SANOFI-AVENTIS BULGARIA EOOD Alexandar Stamboliyski blvd.
SANOFI- AVENTIS BULGARIA TRITACE 2. 5 EOOD Alexandar Stamboliyski blvd.
TRITACE 2.5 PLUS 2.5 mg / 12.5mg TRITACE 5 PLUS 5 mg/ 25mg
PLUS TRITACE 5 PLUS
SANOFI-AVENTIS CYPRUS LTD 14, Charalambou Mouskou street 2015 – Nicosia Cyprus
SANOFI- AVENTIS CYPRUS LTD TRIATEC PLUS 14, Charalambou Mouskou street 2015 – Nicosia Küpros
TRIATEC PLUS 5mg / 25mg
5mg / 25mg
Evropská 2590/ 33c
TRITAZIDE 2. 5/ 12. 5mg Evropská 2590/ 33c TRITAZIDE 5/ 25mg 16000 Praha 6 Tšehhi Vabariik
TRITAZIDE 2.5/ 12.5mg 2.5 mg / 12.5mg TRITAZIDE 5/ 25mg 5 mg/ 25mg
2, 5 mg / 12, 5mg 5 mg/ 25mg
Pharmaceutical Form
EÜ/ EMÜ liikmesriik
sanofi-aventis Denmark A/ S Slotsmarken 13 2970 Hørsholm Denmark
Müügiloa hoidja 2970 Hørsholm Taani
TRIATEC COMP
(Väljamõeldud) nimi
5mg/ 25mg
Tugevus
Tablet
Ravimvorm
Oral
Manustamistee
SANOFI-AVENTIS DEUTSCHLAND GMBH 65926 Frankfurt am Main Germany
SANOFI- AVENTIS DEUTSCHLAND GMBH 65926 Frankfurt am Main Saksamaa
2.5 mg / 12.5mg
2, 5 mg / 12, 5mg
SANOFI-AVENTIS ESTONIA OÜ Pärnu mnt.
SANOFI- AVENTIS EESTI OÜ Pärnu mnt.
139 E/ 2 11317 Tallinn Estonia
139 E/ 2 11317 Tallinn Eesti
SANOFI-AVENTIS OY Huopalahdentie 24 00350 Helsinki Finland
SANOFI- AVENTIS OY Huopalahdentie 24 00350 Helsinki Soome
SANOFI-AVENTIS France 1-13, boulevard Romain Rolland 75014 Paris France
SANOFI- AVENTIS France 1- 13, boulevard Romain Rolland 75014 Paris Prantsusmaa
5mg/ 12.5mg
5mg/ 12, 5mg
SANOFI-AVENTIS DEUTSCHLAND GMBH Brüningstraße 50 65926 Frankfurt am Main Germany
SANOFI- AVENTIS DEUTSCHLAND GMBH Brüningstraße 50 65926 Frankfurt am Main Saksamaa
Delix 2,5 plus Delix 5 plus
Delix 2, 5 plus Delix 5 plus
2.5 mg / 12.5mg 5 mg/ 25mg
2, 5 mg / 12, 5mg 5 mg/ 25mg
5
5 56218 Mülheim- Kärlich Saksamaa
Ramilich comp 2.5 mg / 12.5 mg Taletten
Ramilich comp 2. 5 mg / 12. 5 mg Taletten Ramilich comp 5 mg / 25 mg Tablettten
2.5 mg / 12.5mg
2, 5 mg / 12, 5mg 5 mg/ 25mg
56218 Mülheim-Kärlich Germany
Saksamaa
Ramilich comp 5 mg / 25 mg Tabletten
RamiWin comp 2. 5 mg/ 12. 5 mg Tablettten