FrancophonIA/ELRC3.0 huggingface dataset:
English: The patients should be instructed to discontinue alendronate and seek medical attention if they develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing, retrosternal pain or new/worsened heartburn.
Bulgarian: sollten darauf hingewiesen werden, Alendronat bei Symptomen einer Ösophagusreizung wie Dysphagie, Schmerzen beim Schlucken, retrosternalen Schmerzen oder neu aufgetretenem/sich verschlimmerndem Sodbrennen abzusetzen und den Arzt aufzusuchen.
English: You should check with your doctor or pharmacist if you are not sure.
Bulgarian: Bitte fragen Sie bei Ihrem Arzt oder Apotheker nach, wenn Sie
English: PACKAGE LEAFLET
Bulgarian: PACKUNGSBEILAGE
English: If you think any of these apply to you, do not take the tablets.
Bulgarian: Nehmen Sie die Tabletten nicht ein, wenn Sie der Meinung sind, dass einer oder mehrere dieser Umstände auf Sie zutreffen.
English: 5) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking Alendronate HEXAL and contact your doctor.
Bulgarian: 5) Wenn bei Ihnen Schwierigkeiten oder Schmerzen beim Schlucken, Schmerzen hinter dem Brustbein, neu einsetzendes oder
English: Gastric ulcer Oesophageal ulcer Musculoskeletal Musculoskeletal pain (bone, muscle or joints) Muscle cramps Neurological Headache
Bulgarian: Schmerzen am Bewegungsapparat (Knochen, Muskeln oder Gelenke) Muskelkrämpfe
English: Gastrointestinal Abdominal pain Dyspepsia
Bulgarian: Aufgetriebenes Abdomen Obstipation
English: Very rare: severe skin reactions perforation of the gullet (oesophagus - the tube that connects your mouth with your stomach) was reported in isolated cases
Bulgarian: In Einzelfällen wurde über einen Durchbruch der Speiseröhre (Ösophagus - die Röhre, die Ihren Mund mit Ihrem Magen verbindet) berichtet.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Bulgarian: NAME UND ANSCHRIFT DES PHARMAZEUTISCHEN UNTERNEHMERS [siehe Annex I - ist national auszufüllen]
English: Uncommon (≥1/1000, <1/100): Rash, pruritus, erythema.
Bulgarian: Gelegentlich (≥ 1/1000, < 1/100): Exanthem, Pruritus, Erythem Selten (≥ 1/10.000, < 1/1.000):
English: Animal studies revealed effects on foetal bone formation at high doses.
Bulgarian: Über die Anwendung von Alendronat bei schwangeren Frauen liegen keine ausreichenden Daten vor. In Tierstudien wurden bei hohen Dosen Wirkungen auf die fetale Knochenbildung beobachtet.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Bulgarian: Informieren Sie bitte Ihren Arzt oder Apotheker, wenn eine der aufgeführten Nebenwirkungen Sie erheblich beeinträchtigt oder Sie Nebenwirkungen bemerken, die nicht in dieser Gebrauchsinformation angegeben
English: Common: ≥ 1/100 - < 1/10
Bulgarian: Häufig:≥1/100 - <1/10
English: “How to take Alendronate HEXAL”.
Bulgarian: „Wie ist Alendronate HEXAL einzunehmen?“ befolgen.
English: Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis) has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered bisphosphonates.
Bulgarian: Zahnextraktion und/oder einer lokalen Infektion (einschließlich Osteomyelitis) über eine Osteonekrose des Kiefers berichtet.
English: MARKETING AUTHORISATION NUMBER(S) <[To be completed nationally]>
Bulgarian: ZULASSUNGSNUMMERN <[ist national auszufüllen]>
English: HOW TO TAKE ALENDRONATE HEXAL
Bulgarian: WIE IST ALENDRONATE HEXAL EINZUNEHMEN?
English: 6.6 Special precautions for disposal
Bulgarian: 6.6 Besondere Vorsichtsmaßnahmen für die Beseitigung Keine besonderen Anforderungen.
English: Oral use
Bulgarian: Körperliche Bewegung
English: If you are being treated by a dentist or if you are going to have dental surgery, tell your dentist that you are taking Alendronate HEXAL.
Bulgarian: Informieren Sie Ihren Zahnarzt, dass Sie Alendronate HEXAL einnehmen, wenn Sie
English: A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).
Bulgarian: Bei Patienten mit gleichzeitig bestehenden Risikofaktoren (z. B. Krebs, Chemotherapie, Radiotherapie, Kortikosteroidtherapie, mangelhafte Mundhygiene) sollte vor Behandlungsbeginn mit Bisphosphonaten eine zahnärztliche Untersuchung mit entsprechenden prophylaktischen Maßnahmen in Erwägung gezogen werden.
English: METHOD AND ROUTE OF ADMINISTRATION For oral use.
Bulgarian: HINWEISE ZUR UND ART(EN) DER ANWENDUNG Zum Einnehmen.
English: MARKETING AUTHORISATION HOLDER <[See Annex I - To be completed nationally]
Bulgarian: INHABER DER ZULASSUNG [siehe Annex I - ist national auszufüllen]
English: For post-menopausal women who are not receiving oestrogen treatment the recommended dose is one 10 mg tablet daily.
Bulgarian: Die empfohlene Dosis für postmenopausale Frauen, die keine Östrogentherapie erhalten, beträgt einmal
English: EXPIRY DATE
Bulgarian: Das Verfalldatum bezieht
English: It reduces the risk of spine and hip fractures.
Bulgarian: Alendronsäure vermindert das Risiko für Wirbel- und Hüftbrüche.
English: - This medicine has been prescribed for you.
Bulgarian: - Dieses Arzneimittel wurde Ihnen persönlich verschrieben. Geben Sie es nicht an Dritte weiter.
English: - If you have any further questions, ask your doctor or pharmacist.
Bulgarian: - Wenn Sie weitere Fragen haben, wenden Sie
English: Pharmaceutical Form
Bulgarian: PHARMAZEUTISCHE ANGABEN
English: In these women the increases (relative to placebo) with alendronate 10 mg once daily were greater than for alendronate 5 mg once daily in the spine (4.11 % versus 1.56 %) and trochanter (2.84 % versus 1.67 %).
Bulgarian: Wirbelsäule (4,11 % versus 1,56 %) und Trochanter (2,84 % versus 1,67 %).
English: 4.9 Overdose
Bulgarian: Überdosierung
English: Whereas
Bulgarian: sind,
English: Uncommon: ≥ 1/1,000 - < 1/100
Bulgarian: Gelegentlich: ≥ 1/1,000 - < 1/100
English: In addition, other amendments to the Summary of Product Characteristics, labelling and package leaflet not in relation with the outcome of the referral procedure were included in accordance with the Guideline on Summary of Product Characteristics, excipient guideline and the latest Quality Review of Document templates.
Bulgarian: Zusammenfassung der Merkmale des Arzneimittels, der Leitlinie über Hilfsstoffe und den neuesten Vorlagen der Arbeitsgruppe Qualitätskontrolle von Dokumenten (QRD) vorgenommen.
English: Musculoskeletal and connective tissue disorders:Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates.
Bulgarian: Osteonekrose des Kiefers wurde bei Patienten berichtet, die mit Bisphosphonaten behandelt wurden.
English: The recommended dosage is 10 mg once daily.
Bulgarian: täglich 1 Tablette zu 10 mg.
English: HOW TO STORE ALENDRONATE HEXAL
Bulgarian: WIE IST ALENDRONATE HEXAL AUFZUBEWAHREN?
English: Magnesium stearate
Bulgarian: Blähungen saures Aufstoßen
English: NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Bulgarian: NAME DES PHARMAZEUTISCHEN UNTERNEHMERS [siehe Annex I - ist national auszufüllen]
English: Nausea
Bulgarian: Bauchschmerzen
English: Do not make yourself vomit, and do not lie down.
Bulgarian: Vermeiden Sie Maßnahmen, die zum Erbrechen führen, und legen Sie
English: Alendronate HEXAL tablets must be taken on an empty stomach immediately on rising in the morning, with plain water only, at least 30 minutes before the first food, drink or other medication of the day.
Bulgarian: Die Tablette darf nur mit Leitungswasser mindestens 30 Minuten vor der ersten Mahlzeit, dem ersten Getränk oder der Einnahme anderer Arzneimittel für diesen Tag eingenommen werden.
English: Excipient: 103.95 mg lactose monohydrate per tablet For a full list of excipients see section 6.1.
Bulgarian: Sonstiger Bestandteil: 103.95 mg Laktose pro Tablette
English: SPECIAL STORAGE CONDITIONS Do not store above 25 °C.
Bulgarian: 6.4 Besondere Vorsichtsmaßnahmen für die Aufbewahrung Nicht über 25 °C lagern.In der Originalverpackung aufbewahren, um den Inhalt vor Feuchtigkeit zu schützen.
English: (see section 5.1).
Bulgarian: siehe Abschnitt 6.1.
English: - Keep this leaflet.
Bulgarian: - Heben Sie die Packungsbeilage auf.
English: Dysphagia
Bulgarian: Durchfall
English: The active substance is alendronate sodium trihydrate.
Bulgarian: ist Natriumalendronat-Trihydrat.
English: If you forget to take Alendronate HEXAL
Bulgarian: Wenn Sie die Einnahme von Alendronate
English: Eye disorders: Rare (≥1/10,000, <1/1000): Uveitis, scleritis, episcleritis
Bulgarian: Augenerkrankungen Selten (≥ 1/10.000, < 1/1.000):
English: If you have been told by your doctor that you have an intolerance to some sugars (for example lactose), contact your doctor before taking this medicine.
Bulgarian: Bitte nehmen Sie Alendronate HEXAL daher erst nach Rücksprache mit Ihrem Arzt ein, wenn Ihnen bekannt ist, dass Sie unter einer Unverträglichkeit gegenüber bestimmten Zuckern, wie Lactose, leiden.
English: 4.1 Therapeutic indications
Bulgarian: 4.1 Anwendungsgebiete
English: Applicant
Bulgarian: Zum Einnehmen
English: EXP
Bulgarian: Resorption
English: BEFORE YOU TAKE ALENDRONATE HEXAL
Bulgarian: In den 30 Minuten nach Einnahme von Alendronate HEXAL sollen
English: Common: headache abdominal pain uncomfortable feeling in the stomach or belching after eating constipation full or bloated feeling in the stomach diarrhoea flatulence heartburn difficulty swallowing pain upon swallowing ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) which can cause chest pain, heartburn or difficulty or pain upon swallowing bone, muscle and/or joint pain
Bulgarian: Geschwüre der Speiseröhre (Ösophagus - die Röhre, die Ihren Mund mit Ihrem Magen verbindet), die Schmerzen im Brustkorb, Sodbrennen und Beschwerden oder Schmerzen beim Schlucken verursachen können.
English: Croscarmellose sodium
Bulgarian: Bauchschmerzen Dyspepsie
English: Acid regurgitation Nausea
Bulgarian: Saures Aufstoßen Übelkeit
English: PHARMACEUTICAL PARTICULARS
Bulgarian: Pharmazeutischer Unternehmer und Hersteller
English: No other clinically significant active substance interactions are expected.
Bulgarian: Andere klinisch signifikante Arzneimittelwechselwirkungen
English: For oral use only.
Bulgarian: Bei einer oralen
English: Alendronic acid
Bulgarian: Schweden - Alendronat
English: • If you have any questions, you should contact your doctor or pharmacist.
Bulgarian: Ако имате някакви въпроси, свържете се с Вашия лекар или фармацевт.
English: European legislation requires that there is a coordinated European approach when a Member State takes regulatory action in relation to a medicine that is authorised in more than one country.
Bulgarian: Европейското законодателство изисква координиран подход в Европа, когато държава членка предприеме нормативно действие във връзка с лекарство, разрешено за употреба в повече от една държава.
English: In order to ensure that these patients will not be left without treatment, national competent authorities may make these medicines available under controlled conditions.
Bulgarian: За да гарантират, че тези пациенти няма да останат без лечение, компетентните национални органи могат да разрешат предлагането на тези лекарства при контролирани условия.
English: The review of oral ketoconazole was initiated in July 2011 at the request of France, under Article 31 of Directive 2001/83/EC.
Bulgarian: Прегледът на данните относно перорален кетоканозол започва през юли 2011 г. по молба на Франция, съгласно член 31 от Директива 2001/83/ЕО.
English: The Committee also considered the advice from a group of experts in the treatment of infections.
Bulgarian: Комитетът взема предвид и препоръките на група специалисти в лечението на инфекции.
English: • The onset of hepatotoxicity occurred generally between 1 and 6 months after starting treatment, but has also been reported earlier than 1 month after starting treatment, and at the recommended daily dose of 200 mg.
Bulgarian: Като цяло хепатотоксичност възниква между 1 и 6 месеца след началото на лечението, но е съобщавана и по-рано от 1 месец след началото на лечение с препоръчителната дневна доза от 200 mg.
English: Oral formulations of ketoconazole have been authorised in the EU via national procedures, and are currently available in several EU Member States under various trade names, including Nizoral and Fungoral.
Bulgarian: Лекарствените форми за перорално приложение на кетоконазол са разрешени за употреба в ЕС чрез национални процедури и в момента се предлагат в няколко държави членки под различни търговски имена, включително Nizoral и Fungoral.
English: The review of oral ketoconazole was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for all questions concerning medicines for human use, which adopted the EMA's final opinion.
Bulgarian: Преразглеждането на перорален кетоконазол е извършено от Комитета по лекарствените продукти за хуманна употреба (CHMP) на EMA, отговарящ за всички въпроси, засягащи лекарствата за хуманна употреба, който приема окончателното становище на EMA.
English: The CHMP was concerned that reports of liver injury occurred early after starting treatment with recommended doses, and it was not possible to identify measures to adequately reduce this risk.
Bulgarian: CHMP изрази безпокойство, че съобщенията за чернодробни увреждания възникват на ранен етап след начало на лечение с препоръчителните дози, както и че не е възможно да се определят мерки за адекватно намаляване на този риск.
English: The CHMP opinion was sent to the European Commission, which endorsed it and adopted a final legally binding decision valid throughout the EU on 11 October 2013.
Bulgarian: Становището на CHMP е изпратено до Европейската комисия, която го одобрява и приема окончателното правнообвързващо решение, валидно в целия ЕС, на 11 октомври 2013 г.
English: • The risk minimisation measures proposed, such as limiting the treatment duration or restricting the use to patients refractory or intolerant to alternative treatments and to physicians experienced in treating rare fungal infections, were not considered sufficient to reduce the risk of hepatotoxicity to an acceptable level.
Bulgarian: Предложените мерки за минимизиране на риска като ограничаване на продължителността на лечение, ограничаване на употребата при пациенти, които не отговарят на или са развили непоносимост към алтернативните терапии, и разрешаване на предписването единствено от лекари с опит в лечението на редки гъбични инфекции, не са счетени за достатъчни за намаляване на риска от хепатотоксичност до приемливо ниво.
English: The Agency's recommendations are based on a review by the Committee for Medicinal Products for Human Use (CHMP), which looked at available data on the benefits of oral ketoconazole and the risk of hepatotoxicity from pre-clinical and clinical studies, post-marketing spontaneous case reports, epidemiological studies and the scientific literature.
Bulgarian: Препоръките на Агенцията се основават на прегледа на Комитета по лекарствените продукти за хуманна употреба (CHMP), който разглежда наличните данни относно ползите от перорален кетоконазол и риска от хепатотоксичност от предклинични и клинични проучвания, спонтанни съобщения след пускане на пазара, епидемиологични проучвания и научната литература.
English: Guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal disease CHMP/EWP/1343/01 Rev. 1, Apr 2010.
Bulgarian: invasive fungal disease CHMP/EWP/1343/01 Rev. 1, Apr 2010.
English: To lift the suspension, the marketing authorisation holder for oral ketoconazole will have to provide convincing data that identify a group of patients in whom the benefits of the medicine outweigh their risks.
Bulgarian: За да бъде отменено временното спиране, притежателят на разрешението за употреба на перорален кетоконазол трябва да предостави убедителни данни, посочващи група пациенти, при които ползите от лекарството надвишават рисковете.
English: • The efficacy studies on oral ketoconazole are limited and have not been carried out in line with the most recently agreed guidelines2.
Bulgarian: Проучванията за ефикасност на перорален кетоконазол са ограничени и не са извършени съгласно най-новите одобрени насоки2.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision valid throughout the EU.
Bulgarian: Становището на CHMP е изпратено до Европейската комисия, която издава окончателното правнообвързващо решение, валидно в целия ЕС.
English: The Committee also concluded that the clinical benefit of oral ketoconazole is uncertain as data on its effectiveness are limited and do not meet current standards, and alternative treatments are available.
Bulgarian: Комитетът заключи, че клиничната полза от перорален кетоконазол е несигурна, тъй като данните за неговата ефективност са ограничени и не отговарят на текущите стандарти, както и че са налични алтернативни терапии.
English: Taking into account the increased rate of liver injury and the availability of alternative antifungal treatments, the CHMP concluded that the benefits did not outweigh the risks.
Bulgarian: Като се вземе предвид високия процент на чернодробни увреждания и наличието на алтернативни противогъбични терапии, CHMP стига до заключението, че ползите не надвишават рисковете.
English: There are also inadequate data to support the efficacy of ketoconazole when other treatments have failed or are not tolerated, or resistance has been detected.
Bulgarian: Освен това не са налични достатъчно данни, които подкрепят ефикасността на кетоконазол, когато другите лечения не дават резултат, няма поносимост към тях или се открива резистентност.
English: Consequently, the French agency asked the EMA to carry out a full assessment of the benefitrisk balance of oral ketoconazole-containing medicines and to issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the EU.
Bulgarian: Впоследствие френската агенция иска EMA да извърши пълна оценка на съотношението полза/риск на съдържащите кетоконазол лекарства за перорално приложение и да издаде становище дали разрешенията за употреба следва да бъдат запазени, изменени, временно спрени или оттеглени в ЕС.
English: Ketoconazole is an antifungal medicine used to treat infections caused by dermatophytes and yeasts.
Bulgarian: Кетоконазол е противогъбично лекарство, което се използва за лечение на инфекции, причинени от дерматофити и дрожди.
English: • Topical ketoconazole formulations have very low systemic absorption and may continue to be used as currently approved.
Bulgarian: Лекарствените форми за локално приложение на кетоконазол имат много ниска системна абсорбция и могат да продължат да се използват съгласно действащите условия.
English: References.
Bulgarian: Тел.
English: Ketoconazole taken orally (by mouth) has been authorised in the EU since 1980, and later topical (on the skin) formulations, such as creams, ointments and shampoos, have become available.
Bulgarian: Кетоконазол за перорален прием (през устата) е разрешен за употреба в ЕС от 1980 г., а по-късно започват да се предлагат и лекарствени форми за локално приложение (върху кожата) като кремове, мехлеми и шампоани.
English: The French medicine agency, the National Agency for the Safety of Medicine and Health Products (ANSM), concluded that the benefit-risk balance of oral ketoconazole was negative because of a high level of liver injury associated with the medicine and in view of the currently available alternative treatments, which are deemed to be safer.
Bulgarian: Френската агенция по лекарствата, Националната агенция за безопасност на лекарствените и здравните продукти (ANSM), заключи, че съотношението полза/риск за перорален кетоконазол е отрицателно поради високите нива на чернодробни увреждания, свързани с лекарството, и с оглед на наличните към момента алтернативни терапии, които се считат за по-безопасни.
English: The European Medicines Agency is aware that ketoconazole is used off-label for treating patients with Cushing's syndrome.
Bulgarian: Европейската агенция по лекарствата взема предвид, че кетоконазол се използва извън одобрените показания за лечение на пациенти със синдром на Кушинг.
English: In June 2011, the French medicines agency concluded that the benefit-risk balance of oral ketoconazole was negative and suspended the existing marketing authorisations in France.
Bulgarian: През юни 2011 г. френската агенция по лекарствата стига до заключението, че съотношението полза/риск на перорален кетоконазол е отрицателно, и временно спира действащите разрешения за употреба във Франция.
English: • As oral ketoconazole is no longer recommended, doctors should review patients being treated with this medicine for fungal infections, with a view of stopping treatment or choosing an appropriate alternative treatment.
Bulgarian: Тъй като перорален кетоконазол вече не се препоръчва, лекарите трябва да преразгледат лечението на пациентите с това лекарство за гъбични инфекции с оглед на спирането на лечението или избирането на подходящо алтернативно лечение.
English: Doctors should no longer prescribe oral ketoconazole and should review patients' treatment options.
Bulgarian: Лекарите следва да спрат да предписват перорален кетоконазол и да преразгледат вариантите за лечение на пациентите.
English: • Oral (by mouth) ketoconazole has been suspended following a review of data showing higher liver toxicity with this medicine compared with other antifungal medicines.
Bulgarian: Пероралният (за прием през устата) кетоконазол е временно спрян от употреба след преразглеждане на данните, които показват по-висока чернодробна токсичност на това лекарство в сравнение с други противогъбични лекарства.
English: Topical formulations of ketoconazole (such as creams, ointments and shampoos) can continue to be used as the amount of ketoconazole absorbed throughout the body is very low with these formulations.
Bulgarian: Лекарствените форми за локално приложение на кетоконазол (като кремове, мехлеми и шампоани) могат да продължат да се използват, тъй като при тях количеството кетоконазол, абсорбирано от тялото, е много малко.
English: • If you are currently taking oral ketoconazole for fungal infections, you should speak to your doctor at a routine appointment to discuss suitable alternative treatments.
Bulgarian: Ако в момента приемате перорален кетоконазол за гъбични инфекции, при рутинно посещение трябва да обсъдите с Вашия лекар подходящите алтернативни терапии.
English: • Pharmacists should refer patients with a prescription of oral ketoconazole for fungal infections to their treating doctor.
Bulgarian: Фармацевтите трябва да насочват пациентите с рецепти за перорален кетоконазол за гъбични инфекции към техния лекуващ лекар.
English: Having assessed the available data on the risks with oral ketoconazole, the CHMP concluded that, although liver injury such as hepatitis is a known side effect of antifungal medicines, the incidence and the seriousness of liver injury with oral ketoconazole were higher than with other antifungals.
Bulgarian: След оценка на наличните данни за рисковете, свързани с перорален кетоконазол, CHMP заключи, че въпреки че хепатитът е известна нежелана лекарствена реакция при противогъбичните лекарствени продукти, честотата и тежестта на чернодробните увреждания с перорален кетоконазол са по-високи, отколкото при другите противогъбични средства.
English: Benefit of oral ketoconazole does not outweigh risk of liver injury in fungal infections
Bulgarian: Ползите от перорален кетоконазол при лечение на гъбични инфекции не надвишават рисковете от чернодробно увреждане