natgillin/translations-raw huggingface dataset:
С това е задействана процедура по сезиране на CMD(h), като от заявителя е поискано да обоснове приложимостта на подадената в подкрепа на заявлението литература към продукта, за който е подадено заявлението, и да демонстрира, че потенциално по-ниската или по-висока експозиция на фуросемид при употребата на Furosemide Vitabalans спрямо тази след прилагане на продукта, използван при основните клинични проучвания, които са описани в представената литература, няма да повлияе на ефикасността или безопасността.
A referral was thus triggered at the CMD(h) and the applicant was asked to justify that the literature provided in support of this application was applicable to the product applied for and to demonstrate that the potentially lower or higher exposure to furosemide, when Furosemide Vitabalans is used compared to the exposure obtained following administration of the product used in the pivotal clinical studies described in the submitted literature, would not influence efficacy or safety.
как продуктът, съдържащ 40 mg фуросемид, за който е подадено заявление за разрешаване за употреба, би довел до потенциален сериозен риск за общественото здраве.
• how the applied furosemide 40 mg product would cause a potential serious risk to public health
Както е посочено по-горе, данните in vitro, демонстриращи сходство на разтворимостта между Furosemide Vitabalans и други съдържащи фуросемид продукти, не доказват, че бионаличността на тези продукти би била подобна, по-специално с лекарствено вещество от клас IV по BCS (ниска разтворимост, ниска пропускливост).
As discussed previously, in vitro data demonstrating similarity of dissolution profiles between Furosemide Vitabalans and other products containing furosemide do not prove that the bioavailability of these products would be similar, in particular, with a BCS class IV drug substance (low solubility, low permeability).
Освен това заявителят представя набор профили на разтворимост, сравняващи Furosemide Vitabalans с девет други таблетки фуросемид от 40 mg.
Furthermore, the applicant provided a set of dissolution profiles comparing Furosemide Vitabalans with nine other furosemide 40 mg tablets.
Всъщност не може да бъде изключено, че лекарствената форма на продукта в заявлението би имала различно действие по отношение на фармакокинетиката в сравнение с включените в представената литература продукти, съдържащи фуросемид.
Indeed, it cannot be excluded that the formulation of the applied product would behave differently in terms of pharmacokinetics compared to the products containing furosemide included in the submitted literature.
В отговор към CHMP заявителят допълнително се позовава на публикуваните фармакокинетични данни, като представя фармакокинетичните параметри на сходни с Furosemide Vitabalans таблетни форми, както и на различни лекарствени форми (напр. таблетки от 20 mg и др.).
In response to the CHMP, the applicant further referred to published pharmacokinetics data presenting PK parameters of similar tablets formulations to Furosemide Vitabalans as well as different formulations (e.g. tablet 20mg).
Предоставените данни не показват, че Furosemide Vitabalans е сходен с продуктите, описани в подадената литература.
• The provided data do not show that Furosemide Vitabalans is similar to the products described in the submitted literature.
защо безопасността и ефективността му биха се различавали качествено от тези на други продукти, съдържащи 40 mg фуросемид.
• why the safety and efficacy of the applied furosemide 40 mg product would be effectively different than in other furosemide 40 mg products
Въз основа единствено на данните от публикуваната литература не е възможно да се заключи, че фармакокинетичните параметри на Furosemide Vitabalans биха били в същите граници като на останалите посочени таблетки фуросемид от 40 mg.
Based only on published literature data, it is not possible to conclude that the pharmacokinetic parameters of Furosemide Vitabalans would be within the same range than other furosemide 40 mg tablets referred to.
Наличните в литературата фармакокинетични параметри не са достатъчни да се твърди, че Furosemide Vitabalans ще има сходна бионаличност.
The pharmacokinetic parameters available in the literature are not sufficient to claim that Furosemide Vitabalans would have a similar bioavailability.
Фармакокинетични данни
• Pharmacokinetics data
Подаденото от заявителя досие не включва каквито и да било клинични данни in vivo, които биха демонстрирали, че фармакокинетичният профил на Furosemide Vitabalans е сходен с този на включените в представената литература продукти, съдържащи фуросемид.
The dossier submitted by the applicant did not include any in vivo clinical data which could have demonstrated that pharmacokinetic profile of Furosemide Vitabalans is similar to the products containing furosemide included in the submitted literature.
Следователно то се основава на публично достъпни библиографски данни, тъй като резултатите от предклиничните и клиничните изпитвания могат да бъдат заменени с подробни позовавания на публикувана научна литература (общественодостъпна информация), ако може да се демонстрира, че активното вещество на лекарствен продукт е с утвърдено лечебно приложение в
The application for Furosemide Vitabalans is therefore based on publicly available bibliographic data as it is possible to replace results of the pre-clinical and clinical trials by detailed references to published scientific literature (information available in the public domain) if it can be demonstrated that the active substances of a medicinal product have been in well-established medicinal use within the Community for at least ten years, with recognized efficacy and an acceptable level of safety.
Доводът на заявителя, че традиционните производствени методи, както и помощните вещества, широко използвани в таблетните форми, не биха предизвикали потенциално по-ниска или повисока експозиция на фуросемид при употребата на Furosemide Vitabalans (спрямо тази след прилагане на други таблетки фуросемид от 40 mg), не може да се счита за достатъчно доказателство, чрез което да се направи връзка между продукта в заявлението и останалите съдържащи фуросемид продукти, описани в литературата.
The applicant's argument that traditional manufacturing methods as well as excipients widely used in tablet formulations would not cause potential lower or higher exposure to furosemide when Furosemide Vitabalans is used (compared to the exposure obtained following administration of other furosemide 40 mg tablets) cannot be considered as sufficient evidence to bridge the applied product and other furosemide described in the literature.
Заявителят твърди също, че разтворимостта заедно с очевидната фармацевтична еквивалентност доказват връзката между Furosemide Vitabalans и други разрешени за употреба продукти, съдържащи 40 mg фуросемид.
The applicant also argued that dissolution behaviour together with evident pharmaceutical equivalence proves bridging between Furosemide Vitabalans and other authorised furosemide 40mg products.
CHMP не счита за подходящо представеното от него проучване, подкрепящо безопасността на фуросемид (Dormans и сътр.1), тъй като там фуросемид е използван интравенозно, а Furosemide Vitabalans е предназначен за перорално приложение под формата на таблетки от 40 mg.
The study in support of the safety of furosemide (Dormans et al.1) presented by the applicant, was not considered as relevant by the CHMP, as furosemide in this study was used intravenously and Furosemide Vitabalans is intended to be used in oral administration as a 40mg tablet.
Комитетът разглежда известието за сезирането, задействано от Естония по член 29, параграф 4 от Директива 2001/83/ЕО на Съвета.
• The Committee considered the notification of the referral triggered by Estonia under Article 29(4)
Не може да бъде приет доводът на заявителя, че традиционните производствени методи, както и широко използваните помощни вещества, са достатъчни, за да се демонстрира връзка между Furosemide Vitabalans и други продукти с фуросемид.
The applicant's argument that traditional manufacturing methods as well as excipients widely used are sufficient to demonstrate the bridging between Furosemide Vitabalans and other furosemide products cannot be accepted.
Трябва да се прецени дали въпреки съществуващите разлики проучваният продукт може да бъде счетен за подобен на тези, за които е подадено заявление за разрешаване за употреба.
A judgement must be made whether the product studied can be considered as similar to the products, for which application for a marketing authorisation has been made in spite of the existing differences.
CHMP счита, че резултатите от това проучване, показващо сходството между профила на разтворимост на Furosemide Vitabalans и този на останалите представени фуросемидни продукти, не са достатъчни, за да се демонстрират ефикасността и безопасността на продукта, за който е подадено заявлението.
The results of this study showing that Furosemide Vitabalans had a similar dissolution profile as the other furosemide presented were not considered sufficient by the CHMP to demonstrate efficacy and safety of the product applied for.
Твърденията на заявителя, че няма връзка между абсорбираното количество фуросемид и диурезата и че лекарствените форми с контролирано освобождаване и лекарствените форми с незабавно освобождаване водят до почти същата диуреза, не се считат за достатъчни от експертната група, за да се докаже безопасността и ефикасността на Furosemide Vitabalans.
The applicant's arguments that there is no correlation between the absorbed amount of furosemide and the diuresis, and that controlled-released and immediate-released formulation produce almost as much diuresis, were not considered as sufficient by the group to prove the safety and efficacy of Furosemide Vitabalans.
Фармацевтични данни
• Pharmaceutical data
Твърденията на заявителя, че няма връзка между абсорбираното количество фуросемид и диурезата и че лекарствените форми с контролирано освобождава тези с незабавно водят до почти същата диуреза, не се считат за достатъчни да се докаже ефикасността на Furosemide Vitabalans.
The applicant's arguments saying that there is no correlation between the absorbed amount of furosemide and the diuresis, and that controlled-released and immediate-released formulation produce almost as much diuresis, was not considered as sufficient to prove the efficacy of Furosemide Vitabalans.
Трябва да се прецени дали въпреки съществуващите разлики проучваният продукт може да бъде счетен за подобен на този, за който е подадено заявление за разрешаване за употреба.
A judgement must be made whether the product studied can be considered as similar to the product for which application for marketing authorisation has been made in spite of existing differences”.
Въз основа на подадените библиографски данни, разглеждани съвместно с допълнителната фармацевтична документация, заявителят не успява да докаже значението им, за да демонстрира безопасността и ефикасността на Furosemide Vitabalans и свързани с него имена.
On the basis of the bibliographic data submitted, taken together with additional pharmaceutical documentation, the applicant failed to establish the relevance of these data to demonstrate the safety and efficacy of Furosemide Vitabalans and associated names.
„В неклиничните и/или клиничните прегледи трябва да се обясни значението на всички представени данни, имащи отношение към даден продукт, който се различава от продукта, предвиден за пускане на пазара“.
Part II.1.d) of Annex I of Directive 2001/83/EC states that “the non-clinical and/or clinical overviews must explain the relevance of any data submitted which concern a product different from the product intended for marketing.
За да се направи връзка между Furosemide Vitabalans и подобен продукт, се счита за нужен научно валиден подход, какъвто е демонстрирането на сравнима фармакокинетика.
A scientifically valid approach such as the demonstration of comparable pharmacokinetics was considered necessary to bridge Furosemide Vitabalans to a similar product.
Въз основа на подадените библиографски данни, разглеждани съвместно с фармацевтичната документация, заявителят не успява да установи значението им, за да демонстрира безопасността и ефикасността на Furosemide Vitabalans.
On the basis of the bibliographic data submitted, taken together with the pharmaceutical data, the applicant failed to establish the relevance of these data to demonstrate safety and efficacy of Furosemide Vitabalans.
Тя счита, че публикуваната литература и данните относно разтворимостта, предоставени от заявителя, не са достатъчни, за да докажат безопасността и ефикасността на Furosemide Vitabalans.
The ad-hoc expert group considered that the published literature and the dissolution data provided by the applicant were not sufficient to prove the safety and efficacy of Furosemide Vitabalans.
доказателства, че фармакокинетиката на Furosemide Vitabalans позволява безопасната му и ефективна употреба в същата дозировка и при показанията, за които е подадено заявлението.
Therefore, the literature data submitted by the applicant to support the safety and efficacy of furosemide did not provide sufficient evidence that the pharmacokinetics of Furosemide Vitabalans allow its safe and effective use in the same dosage and indications applied for.
За да се демонстрират безопасността и ефикасността на Furosemide Vitabalans, ще са необходими допълнителни данни в подкрепа на значението на библиографските такива.
Additional data would be needed to support the relevance of the bibliographic data to demonstrate the safety and efficacy of Furosemide Vitabalans.
360 ELISA единици
360 ELISA Units
10 микрограма
10 micrograms
Хепатит B повърхностен антиген
Hepatitis B surface antigen3,4
1Произведен в човешки диплоидни (MRC-5) клетки 2Адсорбирани върху алуминиев хидроксид, хидратиран
1Produced on human diploid (MRC-5) cells 2Adsorbed on aluminium hydroxide, hydrated
Произведен в дрождеви клетки (Saccharomyces cerevisiae) чрез рекомбинантна ДНК технология
3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate
Опаковка
Pack size
1 предварително напълнена спринцовка без игла
1 pre-filled syringe without needle
Хепатит A вирус (инактивиран)
1 dose (0.5 ml): Hepatitis A virus (inactivated)1,2
Количество в опаковка
Immediate Packaging
Път на въвеждане
EMA procedure number
Лекарств ена форма
(Invented) name Strength Pharmaceutical form Route of administration
Dit betekent dat het een lange werkingsduur heeft.
This means it has a long duration of action.
Deze samenvatting is voor het laatst bijgewerkt in 07-2016.
This summary was last updated in 07-2016.
De Europese Commissie heeft op 21 januari 2013 een in de hele Europese Unie geldige vergunning voor het in de handel brengen van Ryzodeg verleend.
The European Commission granted a marketing authorisation valid throughout the European Union for Ryzodeg on 21 January 2013.
Overige informatie over Ryzodeg
Other information about Ryzodeg
Dit document is een samenvatting van het Europees openbaar beoordelingsrapport (EPAR) voor Ryzodeg.
This is a summary of the European public assessment report (EPAR) for Ryzodeg.
De dosis Ryzodeg wordt voor elke patiënt afzonderlijk bepaald.
The dose of Ryzodeg is determined individually for each patient.
Welke maatregelen worden er genomen om een veilig en doeltreffend gebruik van Ryzodeg te waarborgen?
What measures are being taken to ensure the safe and effective use of Ryzodeg?
Aanbevelingen en voorzorgsmaatregelen die professionele zorgverleners en patiënten in acht moeten nemen voor een veilig en doeltreffend gebruik van Ryzodeg, zijn opgenomen in de samenvatting van de productkenmerken en de bijsluiter.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ryzodeg have been included in the summary of product characteristics and the package leaflet.
EPAR-samenvatting voor het publiek
EPAR summary for the public
Welke voordelen bleek Ryzodeg tijdens de studies te hebben?
What benefit has Ryzodeg shown during the studies?
Dit geneesmiddel is uitsluitend op doktersvoorschrift verkrijgbaar.
The medicine can only be obtained with a prescription.
Alle studies onder volwassenen duurden zes maanden, maar één studie werd verlengd tot een jaar. De studies onder kinderen duurden 16 weken.
All the studies in adults lasted six months, but one was extended to one year.
Het middel is verkrijgbaar in de vorm van een oplossing voor injectie in een patroon (100 eenheden/ml) en in een voorgevulde pen (100 eenheden/ml).
It is available as a solution for injection in a cartridge (100 units/ml) and in a pre-filled pen (100 units/ml).
Het CHMP heeft geconcludeerd dat de voordelen van Ryzodeg groter zijn dan de risico's, en heeft geadviseerd een vergunning te verlenen voor het in de handel brengen van dit middel.
The CHMP decided that Ryzodeg's benefits are greater than its risks and recommended that it be given marketing authorisation.
Ryzodeg wordt een- of tweemaal daags geïnjecteerd, bij de maaltijd.
Ryzodeg is injected once or twice a day, at mealtimes.
Het CHMP concludeerde dat Ryzodeg in het algemeen veilig is en dat de bijwerkingen ervan vergelijkbaar zijn met die van andere insulineanalogen.
The Committee concluded that Ryzodeg is generally safe and its side effects are comparable to those of other insulin analogues.
Het middel wordt toegediend als een injectie onder de huid in de buikwand (aan de voorzijde van de taille), bovenarm of dij.
It is given as an injection under the skin in the abdominal wall (at the front of the waist), upper arm or thigh.
De HbA1c-concentratie geeft aan hoe goed de bloedglucose wordt gereguleerd.
HbA1c gives an indication of how well the blood glucose is controlled.
In de studies naar diabetes type 2 werd Ryzodeg alleen of in combinatie met andere geneesmiddelen voor diabetes gegeven.
In the studies in type 2 diabetes, Ryzodeg was either given alone or in combination with other antidiabetes medicines.
Deze verschillen hebben tot gevolg dat insuline degludec langzamer door het lichaam wordt opgenomen.
The differences mean that insulin degludec is absorbed more slowly by the body.
Wat is Ryzodeg?
What is Ryzodeg?
stabiel zijn en jonge kinderen de symptomen van hypoglykemie niet kunnen duiden, is Ryzodeg niet geschikt voor kinderen jonger dan twee jaar.
Because the dose requirements in young children may not be stable and because they cannot express symptoms of hypoglycaemia, Ryzodeg is not suitable for children aged under 2 years.
De vervangende insuline werkt op dezelfde wijze als natuurlijke insuline en helpt bij de opname van glucose uit het bloed in de cellen.
The replacement insulin acts in the same way as natural insulin, and helps glucose from the blood to enter cells.
Ryzodeg wordt gebruikt voor de behandeling van diabetes bij volwassenen, jongeren en kinderen ouder dan twee jaar.
Ryzodeg is used to treat diabetes in adults, adolescents and children from 2 years of age.
De meest gemelde bijwerking tijdens behandeling met Ryzodeg is hypoglykemie (lage bloedglucosespiegel).
The most frequently reported side effect during treatment with Ryzodeg is hypoglycaemia (low blood glucose levels).
De werkzame stoffen van Ryzodeg, insuline degludec en insuline aspart, worden vervaardigd met behulp van een methode die bekendstaat als ‘recombinant DNA-techniek', en wel door een gist waarin een gen (DNA) is ingebracht, zodat beide stoffen kunnen worden aangemaakt.
The active substances in Ryzodeg, insulin degludec and insulin aspart, are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes the yeast able to produce them.
Waarom is Ryzodeg goedgekeurd?
Why has Ryzodeg been approved?
Ryzodeg insuline degludec/insuline aspart
Ryzodeg insulin degludec / insulin aspart
Ook werd in de studies onder volwassenen opgemerkt dat Ryzodeg 's nachts het risico op hypoglykemie verlaagt bij patiënten met diabetes type 1 en type 2.
It also noted that in the studies with adults Ryzodeg reduces the risk of hypoglycaemia during the night in patients with type 1 and type 2diabetes.
Ryzodeg is een geneesmiddel dat de werkzame stoffen insuline degludec en insuline aspart bevat.
Ryzodeg is a medicine that contains the active substances insulin degludec and insulin aspart.
Ryzodeg is een insulineanaloog, een vervanger voor de normaliter door het lichaam aangemaakte insuline.
Ryzodeg is a replacement insulin for the insulin normally made by the body.
Het CHMP concludeerde dat Ryzodeg werkzaam is wat betreft het reguleren van de bloedglucosespiegel bij volwassenen, jongeren en kinderen ouder dan twee jaar met diabetes.
The CHMP concluded that Ryzodeg is effective in controlling blood glucose levels in adults, adolescents and children aged over 2 years with diabetes.
Het volledige EPAR voor Ryzodeg is te vinden op de website van het Europees Geneesmiddelenbureau: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. Lees de bijsluiter (ook onderdeel van het EPAR) of neem contact op met uw arts of apotheker voor meer informatie over de behandeling met Ryzodeg.
The full EPAR for Ryzodeg can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Ryzodeg is ook onderzocht in een hoofdstudie onder 362 kinderen in de leeftijd van 1
Ryzodeg has also been studied in one main study in 362 children aged between 1 and 17 years with type 1 diabetes.
Welke risico's houdt het gebruik van Ryzodeg in?
What is the risk associated with Ryzodeg?
Diabetes is een ziekte waarbij het lichaam niet voldoende insuline produceert om de bloedsuikerspiegel
Diabetes is a disease in which the body does not produce enough insulin to control the level of blood sugar or when the body is unable to use insulin effectively.
Insuline degludec en insuline aspart verschillen slechts in geringe mate van humane insuline.
Insulin degludec and insulin aspart are slightly different from human insulin.
Hoe is Ryzodeg onderzocht?
How has Ryzodeg been studied?
te reguleren tot aan de volgende dosis, evenals kortwerkende insuline om de extra suiker uit de maaltijd te helpen verwerken.
Injecting Ryzodeg at a main meal provides long-acting insulin to control blood sugar until the next dose as well as short-acting insulin to help deal with the extra sugar from the meal.
Hoe wordt Ryzodeg gebruikt?
How is Ryzodeg used?
In alle studies werd de spiegel van geglycosyleerde hemoglobine (HbA1c) gemeten.
All of the studies measured the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood attached to glucose.
Hoe werkt Ryzodeg?
How does Ryzodeg work?
De injectieplaats moet bij elke injectie worden gewisseld om de kans op vorming van onderhuidse vetbulten
The place for injection should be altered with each injection to reduce the risk of developing fatty lumps under the skin that can affect the amount of Ryzodeg absorbed into the blood.
samen met een snelwerkende insuline, die bij andere maaltijden wordt geïnjecteerd.
In type 1 diabetes, Ryzodeg is used with rapid-acting insulin, which is injected at other mealtimes.
In de studies naar diabetes type 1 kregen de patiënten ook injecties met
In the studies in type 1 diabetes, patients also received injections of rapid acting insulin at other mealtimes.
Het geeft uitleg over de aanpak van het Comité voor geneesmiddelen voor menselijk gebruik (CHMP) bij de beoordeling van het geneesmiddel, een proces dat
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 Ryzodeg.
Deze behandeling werd vergeleken met een behandeling waarbij insuline detemir een- of tweemaal daags werd toegediend en insuline aspart bij alle maaltijden.
Ryzodeg was given once a day at mealtime with insulin aspart given at other mealtimes and this treatment was compared with treatment comprising insulin detemir given once or twice a day with insulin aspart given at all mealtimes.