FrancophonIA/ELRC3.0 huggingface dataset:
English: Talk to your doctor or pharmacist before taking Procoralan - if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitation, increase in chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an abnormality of electrocardiogram (ECG) called ‘long QT syndrome', - if you have symptoms such as tiredness, dizziness or shortness of breath (this could mean that your heart is slowing down too much), - if you suffer from symptoms of atrial fibrillation (pulse rate at rest unusually high (over 110 beats per minute) or irregular, without any apparent reason, making it difficult to measure), - if you have had a recent stroke (cerebral attack), - if you suffer from mild to moderate low blood pressure, - if you suffer from uncontrolled blood pressure, especially after a change in your antihypertensive treatment, - if you suffer from severe heart failure or heart failure with abnormality of ECG called ‘bundle branch block', - if you suffer from chronic eye retinal disease, - if you suffer from moderate liver problems, - if you suffer from severe renal problems.
Bulgarian: - Ако имате оплаквания като лесна уморяемост, замайване или недостиг на въздух (това би могло да означава, че сърдечната Ви дейност е прекалено бавна), - Ако страдате от симптоми на предсърдно мъждене (необичайно висока честота на пулса в покой (над 110 удара в минута) или неравномерна честота, която се появява без особена причина и се измерва трудно), - Ако наскоро сте прекарали мозъчен инсулт (церебрален пристъп), - Ако страдате от леко до умерено понижено кръвно налягане, - Ако страдате от неконтролирано кръвно налягане, особено след промяна на антихипертензивното Ви лечение, - Ако страдате от тежка сърдечна недостатъчност или от сърдечна недостатъчност с промяна в ЕКГ, наречена „бедрен блок ”, - Ако страдате от хронично заболяване на ретината на окото, - Ако страдате от умерено чернодробно увреждане,
English: Procoralan 7.5 mg tablets are salmon-coloured, triangular, film-coated tablets engraved with “7.5” on one face and on the other.
Bulgarian: Procoralan 7,5 mg са триъгълни филмирани таблетки с розово-оранжев цвят, гравирани с “7,5” от едната и от обратната страна.
English: INFORMATION IN BRAILLE PROCORALAN 5 mg
Bulgarian: PROCORALAN 5 mg
English: INFORMATION IN BRAILLE PROCORALAN 7.5 mg
Bulgarian: PROCORALAN 7,5 mg
English: If you forget to take Procoralan:
Bulgarian: Ако сте пропуснали да приемете Procoralan
English: How to store Procoralan
Bulgarian: Как да съхранявате Procoralan
English: NAME OF THE MEDICINAL PRODUCT Procoralan 5 mg film-coated tablets
Bulgarian: ПРОДУКТ Procoralan 5 mg филмирани таблетки
English: ibutilide, amiodarone).
Bulgarian: бепридил, соталол, ибутилид , амиодарон).
English: If you stop taking Procoralan:
Bulgarian: Ако сте спрели употребата на Procoralan
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/316/008-014
Bulgarian: EU/1/05/316/008-014
English: NAME OF THE MEDICINAL PRODUCT Procoralan 7.5 mg film-coated tablets
Bulgarian: ПРОДУКТ Procoralan 7,5 mg филмирани таблетки
English: Therefore, ivabradine is contra-indicated during breast-feeding (see section 4.3).
Bulgarian: Поради това, ивабрадин е противопоказан по време на кърмене(вж. точка 4.3).
English: Procoralan 5 mg film-coated tablets Procoralan 7.5 mg film-coated tablets ivabradine
Bulgarian: Procoralan 5 mg филмирани таблетки Procoralan 7,5 mg филмирани таблетки
English: Procoralan 5 mg: one film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
Bulgarian: Procoralan 5 mg : една филмирана таблетка съдържа 5 mg ивабрадин (еквивалентно на 5,390 mg ивабрадин като хидрохлорид).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/316/001-007
Bulgarian: EU/1/05/316/001-007
English: Procoralan 7.5 mg: one film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
Bulgarian: Procoralan 7,5 mg: една филмирана таблетка съдържа 7,5 mg ивабрадин (еквивалентно на 8,085 mg ивабрадин като хидрохлорид).
English: If you take more Procoralan than you should:
Bulgarian: Ако сте приели повече от необходимата доза Procoralan
English: Elevated creatinine in blood ECG prolonged QT interval
Bulgarian: QT интервал в ЕКГ
English: România
Bulgarian: Ирландия
English: Procoralan (ivabradine) is a heart medicine used to treat: - Symptomatic stable angina pectoris (which causes chest pain) in adult patients whose heart rate is over or equal to 70 beats per minute.
Bulgarian: - Симптоматична стабилна стенокардия (която предизвиква гръдни болки) при възрастни, със сърдечна честота над или равна на 70 удара в минута).
English: Check with your doctor or pharmacist if you are not sure.
Bulgarian: Говорете с Вашия лекар или фармацевт преди да приемете Procoralan
English: A therapeutic scheme higher than the approved posology was used (starting dose 7.5 mg b.i.d.
Bulgarian: Използвана е била по-висока терапевтична схема от одобрената дозировка (начална доза 7,5 mg два пъти дневно (5 mg два пъти дневно, ако възрастта е ≥ 75 години) и титриране до 10 mg два пъти дневно).
English: The infusion should last around 15 minutes.
Bulgarian: Инфузията продължава около 15 минути.
English: No other major concerns have been identified about the safety of the medicine.
Bulgarian: Не са идентифицирани други сериозни проблеми с безопасността на лекарството.
English: What measures are being taken to ensure the safe and effective use of Respreeza?
Bulgarian: Какви мерки се предприемат, за да се гарантира безопасната и ефективна употреба на Respreeza?
English: The full EPAR for Respreeza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Bulgarian: Пълният текст на EPAR за Respreeza може да се намери на уебсайта на Агенцията: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is not intended to provide practical advice on how to use Respreeza.
Bulgarian: Документът не е предназначен да предоставя практически съвети относно употребата на Respreeza.
English: Allergic reactions have been observed during treatment, some of which were severe.
Bulgarian: По време на лечението са наблюдавани алергични реакции, някои от които тежки.
English: The company that markets Respreeza will carry out a further study to assess whether an increased dose of 120 mg/kg may lead to improved effects compared with the currently recommended dose.
Bulgarian: Фирмата, която предлага Respreeza, ще проведе допълнително проучване, за да оцени дали увеличената доза от 120 mg/kg може да доведе до по-добри ефекти в сравнение с настоящата препоръчителна доза.
English: This is a summary of the European public assessment report (EPAR) for Respreeza.
Bulgarian: Настоящият документ представлява резюме на Европейския публичен оценъчен доклад (EPAR) за Respreeza.
English: Subsequent infusions can be given by a caregiver or by the patient.
Bulgarian: Следващите инфузии могат да бъдат прилагани от болногледач или от пациента.
English: The recommended dose of Respreeza is 60 mg per kilogram body weight, given once a week.
Bulgarian: Препоръчителната доза Respreeza е 60 mg на килограм телесно тегло за приложение веднъж седмично.
English: The decrease in lung density after 24 months was around 2.6 g/l in patients who received Respreeza, compared with a decrease of around 4.2 g/l in patients receiving placebo.
Bulgarian: Намалението на белодробната плътност след 24 месеца е около 2,6 g/l при пациентите, приемащи Respreeza, в сравнение с намаление от около 4,2 g/l при пациентите, приемащи плацебо.
English: Therefore, the Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Respreeza's benefits are greater than its risks and recommended that it be approved for use in the EU.
Bulgarian: Комитетът по лекарствените продукти за хуманна употреба (CHMP) на Агенцията реши, че ползите от Respreeza са по-големи от рисковете, и препоръча Respreeza да бъде разрешен за употреба в ЕС.
English: Other information about Respreeza
Bulgarian: Допълнителна информация за Respreeza:
English: What benefits of Respreeza have been shown in studies?
Bulgarian: Какви ползи от Respreeza са установени в проучванията?
English: For more information about treatment with Respreeza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Bulgarian: За повече информация относно лечението с Respreeza прочетете листовката (също част от EPAR) или попитайте вашия лекар или фармацевт.
English: What are the risks associated with Respreeza?
Bulgarian: Какви са рисковете, свързани с Respreeza?
English: What is Respreeza and what is it used for?
Bulgarian: Какво представлява Respreeza и за какво се използва?
English: Allergic reactions were the main safety concern with Respreeza, but advice on how to manage this risk has been included in the product information.
Bulgarian: Алергичните реакции са основното опасение по отношение на безопасността при Respreeza, но в информацията за продукта е включена препоръка как да се управлява рискът от тях.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Respreeza have also been included in the summary of product characteristics and the package leaflet.
Bulgarian: Препоръките и предпазните мерки за безопасната и ефективна употреба на Respreeza, които да се спазват от здравните специалисти и пациентите, са включени и в кратката характеристика на продукта и в листовката.
English: For practical information about using Respreeza, patients should read the package leaflet or contact their doctor or pharmacist.
Bulgarian: За практическа информация относно употребата на Respreeza пациентите следва да прочетат листовката или да попитат своя лекар или фармацевт.
English: For the full list of all side effects and restrictions with Respreeza, see the package leaflet.
Bulgarian: За пълния списък на всички нежелани лекарствени реакции и ограничения, съобщени при Respreeza, вижте листовката.
English: The most common side effects with Respreeza (which may affect up to 1 in 10 people) are dizziness, headache, dyspnoea (shortness of breath) and nausea.
Bulgarian: Най-честите нежелани лекарствени реакции при Respreeza (които е възможно да засегнат не повече от 1 на 10 души) са замаяност, главоболие, диспнея (задух) и гадене.
English: Because of the risk of severe allergic reactions, Respreeza must not be used in patients who are lacking IgA, a protein in the blood, and who have developed antibodies against it because these patients are more prone to allergic reactions.
Bulgarian: Поради риска от тежки алергични реакции Respreeza не трябва да се използва при пациенти, които имат дефицит на IgA, протеин в кръвта, и развиват антитела срещу него, тъй като тези пациенти са по-склонни към алергични реакции.
English: Respreeza is used to slow down damage to the lungs in patients with severe disease.
Bulgarian: Respreeza се използва за забавяне на увреждането на белите дробове при пациенти с тежка форма на заболяването.
English: In the study, Respreeza was compared with placebo (a dummy treatment) and the main measure of effectiveness was the decrease in lung density.
Bulgarian: В проучването Respreeza е сравнен с плацебо (сляпо лечение), а основният показател за ефективност е намаляването на белодробната плътност.
English: Respreeza is a medicine used in adults with alpha1-proteinase inhibitor deficiency, an inherited disorder that can cause lung problems such as increasing shortness of breath and which may also affect the liver.
Bulgarian: Respreeza е лекарство, което се използва при възрастни с дефицит на алфа1-протеиназен инхибитор - наследствено нарушение, което може да причини белодробни проблеми като нарастващ задух и което може да засегне и черния дроб.
English: Lung density is an indicator of the extent of lung damage: the bigger the decrease in lung density, the greater is the damage to the lung.
Bulgarian: Белодробната плътност е показател за степента на белодробно увреждане: колкото по-голямо е намалението на белодробната плътност, толкова по-голямо е увреждането на белия дроб.
English: How is Respreeza used?
Bulgarian: Как се използва Respreeza?
English: The active substance in Respreeza, human alpha1-proteinase inhibitor, is a natural protein in the blood which protects lung tissue from damage.
Bulgarian: Активното вещество в Respreeza, човешки алфа1-протеиназен инхибитор, е естествен протеин в кръвта, който предпазва белодробната тъкан от увреждане.
English: Respreeza is available as a powder and solvent to be made into a solution for infusion (drip) into a vein.
Bulgarian: Respreeza се предлага под формата на прах и разтворител за приготвяне на разтвор за инфузия (вливане) във вена.
English: The main study with Respreeza showed that the medicine is effective at slowing down the damage to the lungs in patients with alpha1-proteinase inhibitor deficiency, and this effect is considered relevant for patients with severe disease.
Bulgarian: Основното проучване с Respreeza показва, че лекарството е ефективно за забавяне на увреждането на белите дробове при пациенти с дефицит на алфа1-протеиназен инхибитор, като този ефект се счита за значим при пациенти с тежка форма на заболяването.
English: It is obtained from human blood and works by replacing the protein that is lacking in patients with alpha1-proteinase inhibitor deficiency.
Bulgarian: Получава се от човешка кръв и действа чрез замяна на протеина, който липсва при пациенти с дефицит на алфа1-протеиназен инхибитор.
English: Why is Respreeza approved?
Bulgarian: Защо Respreeza е разрешен за употреба?
English: The first infusion should be given under the supervision of a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency.
Bulgarian: Първата инфузия трябва да се приложи под контрола на здравен специалист с опит в лечението на дефицит на алфа1-протеиназен инхибитор.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Respreeza on 20 August 2015.
Bulgarian: Европейската комисия издава разрешение за употреба на Respreeza, валидно в Европейския съюз.
English: Respreeza contains the active substance human alpha1-proteinase inhibitor.
Bulgarian: Respreeza съдържа активното вещество човешки алфа1-протеиназен инхибитор (human alpha1proteinase inhibitor).
English: How does Respreeza work?
Bulgarian: Как действа Respreeza?
English: Respreeza has been shown to slow down lung damage in one main study involving 180 patients with lung damage due to alpha1-proteinase inhibitor deficiency.
Bulgarian: В едно основно проучване, обхващащо 180 пациенти с белодробно увреждане, дължащо се на дефицит на алфа1-протеиназен инхибитор, е показано, че Respreeza забавя белодробното увреждане.
English: This summary was last updated in 04-2013.
Bulgarian: Tento souhrn byl naposledy aktualizován v 04-2013.
English: For patients requiring greater symptom relief, the dose may be increased to 15 mg.
Bulgarian: U pacientů, u kterých je nutné výraznější zmírnění příznaků, může být dávka zvýšena na 15 mg.
English: The main measure of effectiveness was the change in the number of incontinence episodes per week.
Bulgarian: Hlavním měřítkem účinnosti byla změna počtu epizod inkontinence za týden.
English: It must not be used in patients with:
Bulgarian: Nesmí ho užívat pacienti trpící:
English: ‘Prolonged-release' means that darifenacin is released slowly from the tablet over a few hours.
Bulgarian: Pojem „prodloužené uvolňování“ znamená, že darifenacin se uvolňuje z tablety pomalu po dobu několika hodin.
English: The tablets should be swallowed whole with some liquid, and not chewed, divided or crushed.
Bulgarian: Tablety by se měly polykat vcelku a zapíjet tekutinou, neměly by se kousat, dělit ani drtit.
English: The recommended starting dose of Emselex is 7.5 mg once a day.
Bulgarian: Doporučená počáteční dávka přípravku Emselex činí 7,5 mg jednou denně.
English: When the results from all four studies were combined, Emselex was more effective in reducing the number of incontinence episodes than placebo.
Bulgarian: Při souhrnném vyhodnocení výsledků všech čtyř studií byl přípravek Emselex v rámci snižování počtu epizod inkontinence účinnější než placebo.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Emselex on 22 October 2004.
Bulgarian: Evropská komise udělila rozhodnutí o registraci přípravku Emselex platné v celé Evropské unii dne 22.
English: EPAR summary for the public darifenacin
Bulgarian: Souhrn zprávy EPAR určený pro veřejnost darifenacinum
English: The Committee decided that Emselex's benefits are greater than its risks and recommended that it be given marketing authorisation.
Bulgarian: Výbor rozhodl, že přínosy přípravku Emselex převyšují jeho rizika, a proto doporučil, aby mu bylo uděleno rozhodnutí o registraci.
English: The most common side effects with Emselex (seen in more than 1 patient in 10) are dry mouth and constipation.
Bulgarian: Nejčastějšími nežádoucími účinky přípravku Emselex (zaznamenanými u více než 1 pacienta z 10) jsou sucho v ústech a zácpa.
English: This leads to an increase in the capacity of the bladder and changes in the way the bladder contracts, resulting in fewer bladder contractions.
Bulgarian: V důsledku toho dochází ke zvýšení kapacity močového měchýře a ke změnám způsobu jeho stahování (kontrakcí), v důsledku čehož je těchto kontrakcí méně.
English: It is available as prolongedrelease tablets (7.5 mg and 15 mg).
Bulgarian: s prodlouženým uvolňováním (7,5 mg a 15 mg).
English: Emselex has been studied in four main studies in a total of 2,078 male and female patients with symptoms of overactive bladder.
Bulgarian: Přípravek Emselex byl zkoumán ve čtyřech hlavních studiích, do kterých bylo zařazeno celkem 2 078 pacientů a pacientek
English: This helps Emselex to prevent unwanted urination.
Bulgarian: Tím přípravek Emselex přispívá k zabránění nechtěnému močení.
English: • myasthenia gravis (a disease causing muscle weakness);
Bulgarian: myasthenia gravis (onemocněním způsobujícím ochablost svalů),
English: • gastric retention (when the stomach does not empty properly);
Bulgarian: žaludeční retencí (stavem, kdy nedochází k řádnému vyprazdňování žaludku),
English: Emselex must not be taken by patients who are also taking medicines that could affect the way that Emselex is broken down in the body, such as protease inhibitors (used to treat HIV infection, such as ritonavir), or ketoconazole or itraconazole (used to treat fungal infections).
Bulgarian: souběžně užívají léky, které mohou mít vliv na způsob štěpení přípravku Emselex v těle, jako jsou inhibitory proteázy (používané k léčbě infekce HIV, například ritonavir) či ketokonazol nebo itrakonazol (používané k léčbě plísňových infekcí).
English: • toxic megacolon (a very serious complication of colitis).
Bulgarian: toxickým megakolonem (velmi závažnou komplikací zánětu tlustého střeva).
English: The CHMP concluded that Emselex showed an effectiveness similar to that of other anticholinergic medicines used in overactive bladder syndrome.
Bulgarian: Výbor CHMP dospěl k závěru, že přípravek Emselex prokázal podobnou účinnost jako jiná anticholinergika používaná k léčbě syndromu hyperaktivního měchýře.
English: The medicine can only be obtained with a prescription.
Bulgarian: Výdej tohoto léčivého přípravku je vázán na lékařský předpis.
English: It is used to treat the urge incontinence (sudden lack of control over urination), increased urinary frequency (need to urinate frequently) and urgency (sudden urge to pass urine) that are associated with the syndrome.
Bulgarian: se používá u dospělých se syndromem hyperaktivního močového měchýře. Používá se k léčbě nutkavé inkontinence (náhlého stavu nedostatečné kontroly nad močením), zvýšené frekvence močení (časté potřeby močení) a naléhavosti močení (náhlého nutkání k močení), jež s tímto syndromem souvisejí.
English: • severe ulcerative colitis (severe inflammation of the gut causing ulcers and bleeding);
Bulgarian: závažnou ulcerózní kolitidou (závažným zánětem tlustého střeva způsobujícím tvorbu vředů a krvácení),
English: What benefit has Emselex shown during the studies?
Bulgarian: Jaký přínos přípravku Emselex byl prokázán v průběhu studií?
English: Other information about Emselex
Bulgarian: Další informace o přípravku Emselex
English: Emselex is a medicine that contains the active substance darifenacin.
Bulgarian: Emselex je léčivý přípravek, který obsahuje léčivou látku darifenacin.
English: After 12 weeks of treatment, patients receiving Emselex 7.5 mg or 15 mg had 8.8 (68%) or 10.6 (77%) fewer episodes of incontinence per week, respectively, and patients receiving placebo had 7 or 7.5 (54 or 58%) fewer episodes per week.
Bulgarian: 15 mg, snížení o 10,6 (77 %) epizody a pacienti, kterým bylo podáváno placebo, snížení o 7 či 7,5 (54 či 58 %) epizod za týden.
English: The full EPAR for Emselex can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Bulgarian: Plné znění Evropské veřejné zprávy o hodnocení (EPAR) pro přípravek Emselex je k dispozici na internetových stránkách agentury na adrese ema.europa.eu/Find medicine/Human medicines/European public assessment reports. Další informace o léčbě přípravkem Emselex naleznete v příbalové informaci (rovněž součástí zprávy EPAR) nebo kontaktujte svého lékaře či lékárníka.
English: In the bladder, this causes the muscles that push urine out of the bladder to relax.
Bulgarian: V močovém měchýři tak dochází k uvolnění svalů, které z něho vypuzují moč.
English: At the start of the studies, the patients had around 16 incontinence episodes per week.
Bulgarian: Při zahájení studií vykazovali pacienti přibližně 16 epizod inkontinence týdně. Po 12 týdnech léčby zaznamenali pacienti, kterým byl podáván přípravek Emselex
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Emselex.
Bulgarian: Tento dokument je souhrnem Evropské veřejné zprávy o hodnocení (European Public Assessment Report, EPAR) pro přípravek Emselex. Objasňuje, jakým způsobem Výbor pro humánní léčivé přípravky (CHMP) vyhodnotil tento přípravek, aby mohl vypracovat své stanovisko k vydání rozhodnutí o registraci a doporučení ohledně podmínek pro používání přípravku Emselex.
English: What is Emselex?
Bulgarian: Co je Emselex?
English: • uncontrolled narrow-angle glaucoma (increased eye pressure even with treatment);
Bulgarian: glaukomem úzkého úhlu neupraveným léčbou (zvýšeným očním
English: Emselex must not be used in people who are hypersensitive (allergic) to darifenacin or any of the other ingredients.
Bulgarian: s přecitlivělostí (alergií) na darifenacin nebo na kteroukoli další složku tohoto přípravku.
English: How has Emselex been studied?
Bulgarian: Jak byl přípravek Emselex zkoumán?
English: Emselex was used at various doses (from 3.75 mg to 30 mg a day) and compared with placebo (a dummy treatment) or with tolterodine (another medicine used in this condition).
Bulgarian: Přípravek Emselex byl užíván v různých dávkách (od 3,75 mg do 30 mg denně) a porovnáván
English: It blocks a receptor called the ‘muscarinic M3 receptor'.
Bulgarian: Léčivá látka v přípravku Emselex, darifenacin, je anticholinergikum. Blokuje receptor, který se nazývá „muskarinový M3 receptor“.
English: • severe liver problems;
Bulgarian: závažným onemocněním jater,
English: How does Emselex work?
Bulgarian: Jak přípravek Emselex působí?
English: How is Emselex used?
Bulgarian: Jak se přípravek Emselex používá?
English: For the full list of all side effects reported with Emselex, see the package leaflet.
Bulgarian: Úplný seznam nežádoucích účinků hlášených v souvislosti
English: What is the risk associated with Emselex?
Bulgarian: Jaká rizika jsou spojena
English: What is Emselex used for?
Bulgarian: K čemu se přípravek Emselex používá?
English: 20 January 2010
Bulgarian: На 15 януари 2010 г.
English: EMA/32301/2010 EMEA/H/C/1221
Bulgarian: 20 януари 2010 г. EMA/393202/2010 EMEA/H/C/1221