natgillin/translations-raw huggingface dataset:
ÄNDERUNG DER ZUSAMMENFASSUNG DER MERKMALE DES ARZNEIMITTELS, DER ETIKETTIERUNG UND DER PACKUNGSBEILAGE
GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Häufig (≥ 1/100, < 1/10): Bauchschmerzen, Dyspepsie, Obstipation, Diarrhö, Flatulenz, Ösophagusulzera*, Dysphagie*, aufgetriebenes Abdomen, saures Aufstoßen Gelegentlich (≥ 1/1000, < 1/100): Übelkeit, Erbrechen, Gastritis, Ösophagitis*, Ösophaguserosionen*, Meläna
Common (≥1/100, <1/10): Abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcers*, dysphagia*, abdominal distension, acid regurgitation.
Hinweise, um eine ausreichende Resorption von Alendronat zu gewährleisten Alendronate
To obtain satisfactory absorption of alendronate
- Anomalien des Ösophagus und andere Faktoren, die die Ösophagusentleerung verzögern, wie
• Oesophageal abnormalities and other factors that delay oesophageal emptying, such as stricture or achalasia.
Alendronate HEXAL soll nicht vor dem Schlafengehen oder morgens vor dem Aufstehen eingenommen werden.
• Alendronate HEXAL tablets should not be taken at bedtime or before arising for the day.
Alendronate HEXAL soll nur morgens nach dem ersten Aufstehen mit einem ganzen Glas Wasser (mindestens 200 ml) eingenommen werden.
• Alendronate HEXAL tablets should only be swallowed on rising for the day with a whole glass of water (not less than 200 ml or 7 fl. oz).
Osteoporose bei Männern Die empfohlene Dosierung beträgt einmal
Osteoporosis in men: The recommended dosage is 10 mg once daily.
sich nicht an diese Anweisungen halten.
Do not pass it on to others.
10. STAND DER INFORMATION {MM/JJJJ} <[ist national auszufüllen]>
DATE OF REVISION OF THE TEXT <{MM/YYYY}> <[To be completed nationally]>
Die Patienten erhielten ergänzend Kalzium und Vitamin D. Im Vergleich zu Placebo nahm die BMD bei den mit einmal täglich 5 mg Alendronat behandelten Patienten in der Wirbelsäule (2,41 %), im Femurhals (2,19 %) und im Trochanter (1,65 %)
Relative to placebo, BMD increased significantly in the spine (2.41 %), femoral neck (2.19 %) and trochanter (1.65 %) in patients who were treated with alendronate 5 mg once daily.
WIRKSTOFF(E) 1 Tablette enthält 10 mg Alendronsäure (als Natriumalendronat x 3 H2O).
STATEMENT OF ACTIVE SUBSTANCE One tablet contains 10 mg alendronic acid (as sodium alendronate trihydrate).
sich zahnärztlichen Eingriffen unterziehen müssen, das Risiko einer Osteonekrose des Kiefers vermindern könnte.
For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
Mit der kombinierten Anwendung in Zusammenhang stehende unerwünschte Ereignisse wurden bei diesen Patientinnen nicht beobachtet.
No undesirable effects could be related to the combination treatment.
sich mindestens 30 Minuten nach Einnahme der Tablette nicht hin - bleiben Sie in aufrechter Position (im Sitzen, im Stehen oder im Gehen).
3) Do not lie down - stay fully upright (sitting, standing or walking) - for at least 30 minutes after swallowing the tablet.
Arzneimittel für Kinder unzugänglich aufbewahren! Sie dürfen das Arzneimittel nach dem auf der Faltschachtel und der Durchdrückpackung angegebenen Verfallsdatum nicht mehr anwenden.
Do not take the tablets after the expiry date stated on the blister and the carton.
6.3 Dauer der Haltbarkeit
6.3 Shelf life
Gastrointestinal
Gastrointestinal disorders:
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.
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.
Bitte fragen Sie bei Ihrem Arzt oder Apotheker nach, wenn Sie
You should check with your doctor or pharmacist if you are not sure.
PACKUNGSBEILAGE
PACKAGE LEAFLET
Nehmen Sie die Tabletten nicht ein, wenn Sie der Meinung sind, dass einer oder mehrere dieser Umstände auf Sie zutreffen.
If you think any of these apply to you, do not take the tablets.
5) Wenn bei Ihnen Schwierigkeiten oder Schmerzen beim Schlucken, Schmerzen hinter dem Brustbein, neu einsetzendes oder
5) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking Alendronate HEXAL and contact your doctor.
Schmerzen am Bewegungsapparat (Knochen, Muskeln oder Gelenke) Muskelkrämpfe
Gastric ulcer Oesophageal ulcer Musculoskeletal Musculoskeletal pain (bone, muscle or joints) Muscle cramps Neurological Headache
Aufgetriebenes Abdomen Obstipation
Gastrointestinal Abdominal pain Dyspepsia
In Einzelfällen wurde über einen Durchbruch der Speiseröhre (Ösophagus - die Röhre, die Ihren Mund mit Ihrem Magen verbindet) berichtet.
Very rare: severe skin reactions perforation of the gullet (oesophagus - the tube that connects your mouth with your stomach) was reported in isolated cases
NAME UND ANSCHRIFT DES PHARMAZEUTISCHEN UNTERNEHMERS [siehe Annex I - ist national auszufüllen]
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Gelegentlich (≥ 1/1000, < 1/100): Exanthem, Pruritus, Erythem Selten (≥ 1/10.000, < 1/1.000):
Uncommon (≥1/1000, <1/100): Rash, pruritus, erythema.
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.
Animal studies revealed effects on foetal bone formation at high doses.
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
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.
Häufig:≥1/100 - <1/10
Common: ≥ 1/100 - < 1/10
„Wie ist Alendronate HEXAL einzunehmen?“ befolgen.
“How to take Alendronate HEXAL”.
Zahnextraktion und/oder einer lokalen Infektion (einschließlich Osteomyelitis) über eine Osteonekrose des Kiefers berichtet.
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.
ZULASSUNGSNUMMERN <[ist national auszufüllen]>
MARKETING AUTHORISATION NUMBER(S) <[To be completed nationally]>
WIE IST ALENDRONATE HEXAL EINZUNEHMEN?
HOW TO TAKE ALENDRONATE HEXAL
6.6 Besondere Vorsichtsmaßnahmen für die Beseitigung Keine besonderen Anforderungen.
6.6 Special precautions for disposal
Körperliche Bewegung
Oral use
Informieren Sie Ihren Zahnarzt, dass Sie Alendronate HEXAL einnehmen, wenn Sie
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.
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.
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).
HINWEISE ZUR UND ART(EN) DER ANWENDUNG Zum Einnehmen.
METHOD AND ROUTE OF ADMINISTRATION For oral use.
INHABER DER ZULASSUNG [siehe Annex I - ist national auszufüllen]
MARKETING AUTHORISATION HOLDER <[See Annex I - To be completed nationally]
Die empfohlene Dosis für postmenopausale Frauen, die keine Östrogentherapie erhalten, beträgt einmal
For post-menopausal women who are not receiving oestrogen treatment the recommended dose is one 10 mg tablet daily.
Das Verfalldatum bezieht
EXPIRY DATE
Alendronsäure vermindert das Risiko für Wirbel- und Hüftbrüche.
It reduces the risk of spine and hip fractures.
- Dieses Arzneimittel wurde Ihnen persönlich verschrieben. Geben Sie es nicht an Dritte weiter.
- This medicine has been prescribed for you.
- Wenn Sie weitere Fragen haben, wenden Sie
- If you have any further questions, ask your doctor or pharmacist.
PHARMAZEUTISCHE ANGABEN
Pharmaceutical Form
Wirbelsäule (4,11 % versus 1,56 %) und Trochanter (2,84 % versus 1,67 %).
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 %).
Überdosierung
4.9 Overdose
sind,
Whereas
Gelegentlich: ≥ 1/1,000 - < 1/100
Uncommon: ≥ 1/1,000 - < 1/100
Zusammenfassung der Merkmale des Arzneimittels, der Leitlinie über Hilfsstoffe und den neuesten Vorlagen der Arbeitsgruppe Qualitätskontrolle von Dokumenten (QRD) vorgenommen.
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.
Osteonekrose des Kiefers wurde bei Patienten berichtet, die mit Bisphosphonaten behandelt wurden.
Musculoskeletal and connective tissue disorders:Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates.
täglich 1 Tablette zu 10 mg.
The recommended dosage is 10 mg once daily.
WIE IST ALENDRONATE HEXAL AUFZUBEWAHREN?
HOW TO STORE ALENDRONATE HEXAL
Blähungen saures Aufstoßen
Magnesium stearate
NAME DES PHARMAZEUTISCHEN UNTERNEHMERS [siehe Annex I - ist national auszufüllen]
NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Bauchschmerzen
Nausea
Vermeiden Sie Maßnahmen, die zum Erbrechen führen, und legen Sie
Do not make yourself vomit, and do not lie down.
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.
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.
Sonstiger Bestandteil: 103.95 mg Laktose pro Tablette
Excipient: 103.95 mg lactose monohydrate per tablet For a full list of excipients see section 6.1.
6.4 Besondere Vorsichtsmaßnahmen für die Aufbewahrung Nicht über 25 °C lagern.In der Originalverpackung aufbewahren, um den Inhalt vor Feuchtigkeit zu schützen.
SPECIAL STORAGE CONDITIONS Do not store above 25 °C.
siehe Abschnitt 6.1.
(see section 5.1).
- Heben Sie die Packungsbeilage auf.
- Keep this leaflet.
Durchfall
Dysphagia
ist Natriumalendronat-Trihydrat.
The active substance is alendronate sodium trihydrate.
Wenn Sie die Einnahme von Alendronate
If you forget to take Alendronate HEXAL
Augenerkrankungen Selten (≥ 1/10.000, < 1/1.000):
Eye disorders: Rare (≥1/10,000, <1/1000): Uveitis, scleritis, episcleritis
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.
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.
4.1 Anwendungsgebiete
4.1 Therapeutic indications
Zum Einnehmen
Applicant
Resorption
EXP
In den 30 Minuten nach Einnahme von Alendronate HEXAL sollen
BEFORE YOU TAKE ALENDRONATE HEXAL
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.
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
Bauchschmerzen Dyspepsie
Croscarmellose sodium
Saures Aufstoßen Übelkeit
Acid regurgitation Nausea
Pharmazeutischer Unternehmer und Hersteller
PHARMACEUTICAL PARTICULARS
Andere klinisch signifikante Arzneimittelwechselwirkungen
No other clinically significant active substance interactions are expected.
Bei einer oralen
For oral use only.
Schweden - Alendronat
Alendronic acid
Ако имате някакви въпроси, свържете се с Вашия лекар или фармацевт.
• If you have any questions, you should contact your doctor or pharmacist.
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.
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.
За да гарантират, че тези пациенти няма да останат без лечение, компетентните национални органи могат да разрешат предлагането на тези лекарства при контролирани условия.
In order to ensure that these patients will not be left without treatment, national competent authorities may make these medicines available under controlled conditions.
Прегледът на данните относно перорален кетоканозол започва през юли 2011 г. по молба на Франция, съгласно член 31 от Директива 2001/83/ЕО.
The review of oral ketoconazole was initiated in July 2011 at the request of France, under Article 31 of Directive 2001/83/EC.
Комитетът взема предвид и препоръките на група специалисти в лечението на инфекции.
The Committee also considered the advice from a group of experts in the treatment of infections.
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.
• 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
• 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.
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.
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.
invasive fungal disease CHMP/EWP/1343/01 Rev. 1, Apr 2010.
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.
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.
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.
Проучванията за ефикасност на перорален кетоконазол са ограничени и не са извършени съгласно най-новите одобрени насоки2.
• The efficacy studies on oral ketoconazole are limited and have not been carried out in line with the most recently agreed guidelines2.
Становището на CHMP е изпратено до Европейската комисия, която издава окончателното правнообвързващо решение, валидно в целия ЕС.
The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision valid throughout the EU.
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.
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.
Като се вземе предвид високия процент на чернодробни увреждания и наличието на алтернативни противогъбични терапии, CHMP стига до заключението, че ползите не надвишават рисковете.
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.
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.
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.
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.
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.
Кетоконазол е противогъбично лекарство, което се използва за лечение на инфекции, причинени от дерматофити и дрожди.
Ketoconazole is an antifungal medicine used to treat infections caused by dermatophytes and yeasts.
Лекарствените форми за локално приложение на кетоконазол имат много ниска системна абсорбция и могат да продължат да се използват съгласно действащите условия.
• Topical ketoconazole formulations have very low systemic absorption and may continue to be used as currently approved.
Тел.
References.
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.
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.
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.
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.
Европейската агенция по лекарствата взема предвид, че кетоконазол се използва извън одобрените показания за лечение на пациенти със синдром на Кушинг.
The European Medicines Agency is aware that ketoconazole is used off-label for treating patients with Cushing's syndrome.
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.
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.
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.
• 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.
Лекарите следва да спрат да предписват перорален кетоконазол и да преразгледат вариантите за лечение на пациентите.
Doctors should no longer prescribe oral ketoconazole and should review patients' treatment options.
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.
• Oral (by mouth) ketoconazole has been suspended following a review of data showing higher liver toxicity with this medicine compared with other antifungal medicines.
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.
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.