FrancophonIA/ELRC3.0 huggingface dataset:
English: Additional data would be needed to support the relevance of the bibliographic data to demonstrate the safety and efficacy of Furosemide Vitabalans.
Bulgarian: За да се демонстрират безопасността и ефикасността на Furosemide Vitabalans, ще са необходими допълнителни данни в подкрепа на значението на библиографските такива.
English: 360 ELISA Units
Bulgarian: 360 ELISA единици
English: 10 micrograms
Bulgarian: 10 микрограма
English: Hepatitis B surface antigen3,4
Bulgarian: Хепатит B повърхностен антиген
English: 1Produced on human diploid (MRC-5) cells 2Adsorbed on aluminium hydroxide, hydrated
Bulgarian: 1Произведен в човешки диплоидни (MRC-5) клетки 2Адсорбирани върху алуминиев хидроксид, хидратиран
English: 3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate
Bulgarian: Произведен в дрождеви клетки (Saccharomyces cerevisiae) чрез рекомбинантна ДНК технология
English: Pack size
Bulgarian: Опаковка
English: 1 pre-filled syringe without needle
Bulgarian: 1 предварително напълнена спринцовка без игла
English: 1 dose (0.5 ml): Hepatitis A virus (inactivated)1,2
Bulgarian: Хепатит A вирус (инактивиран)
English: Immediate Packaging
Bulgarian: Количество в опаковка
English: EMA procedure number
Bulgarian: Път на въвеждане
English: (Invented) name Strength Pharmaceutical form Route of administration
Bulgarian: Лекарств ена форма
English: This means it has a long duration of action.
Bulgarian: Dit betekent dat het een lange werkingsduur heeft.
English: This summary was last updated in 07-2016.
Bulgarian: Deze samenvatting is voor het laatst bijgewerkt in 07-2016.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ryzodeg on 21 January 2013.
Bulgarian: 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.
English: Other information about Ryzodeg
Bulgarian: Overige informatie over Ryzodeg
English: This is a summary of the European public assessment report (EPAR) for Ryzodeg.
Bulgarian: Dit document is een samenvatting van het Europees openbaar beoordelingsrapport (EPAR) voor Ryzodeg.
English: The dose of Ryzodeg is determined individually for each patient.
Bulgarian: De dosis Ryzodeg wordt voor elke patiënt afzonderlijk bepaald.
English: What measures are being taken to ensure the safe and effective use of Ryzodeg?
Bulgarian: Welke maatregelen worden er genomen om een veilig en doeltreffend gebruik van Ryzodeg te waarborgen?
English: 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.
Bulgarian: 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.
English: EPAR summary for the public
Bulgarian: EPAR-samenvatting voor het publiek
English: What benefit has Ryzodeg shown during the studies?
Bulgarian: Welke voordelen bleek Ryzodeg tijdens de studies te hebben?
English: The medicine can only be obtained with a prescription.
Bulgarian: Dit geneesmiddel is uitsluitend op doktersvoorschrift verkrijgbaar.
English: All the studies in adults lasted six months, but one was extended to one year.
Bulgarian: Alle studies onder volwassenen duurden zes maanden, maar één studie werd verlengd tot een jaar. De studies onder kinderen duurden 16 weken.
English: It is available as a solution for injection in a cartridge (100 units/ml) and in a pre-filled pen (100 units/ml).
Bulgarian: 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).
English: The CHMP decided that Ryzodeg's benefits are greater than its risks and recommended that it be given marketing authorisation.
Bulgarian: 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.
English: Ryzodeg is injected once or twice a day, at mealtimes.
Bulgarian: Ryzodeg wordt een- of tweemaal daags geïnjecteerd, bij de maaltijd.
English: The Committee concluded that Ryzodeg is generally safe and its side effects are comparable to those of other insulin analogues.
Bulgarian: Het CHMP concludeerde dat Ryzodeg in het algemeen veilig is en dat de bijwerkingen ervan vergelijkbaar zijn met die van andere insulineanalogen.
English: It is given as an injection under the skin in the abdominal wall (at the front of the waist), upper arm or thigh.
Bulgarian: Het middel wordt toegediend als een injectie onder de huid in de buikwand (aan de voorzijde van de taille), bovenarm of dij.
English: HbA1c gives an indication of how well the blood glucose is controlled.
Bulgarian: De HbA1c-concentratie geeft aan hoe goed de bloedglucose wordt gereguleerd.
English: In the studies in type 2 diabetes, Ryzodeg was either given alone or in combination with other antidiabetes medicines.
Bulgarian: In de studies naar diabetes type 2 werd Ryzodeg alleen of in combinatie met andere geneesmiddelen voor diabetes gegeven.
English: The differences mean that insulin degludec is absorbed more slowly by the body.
Bulgarian: Deze verschillen hebben tot gevolg dat insuline degludec langzamer door het lichaam wordt opgenomen.
English: What is Ryzodeg?
Bulgarian: Wat is Ryzodeg?
English: 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.
Bulgarian: stabiel zijn en jonge kinderen de symptomen van hypoglykemie niet kunnen duiden, is Ryzodeg niet geschikt voor kinderen jonger dan twee jaar.
English: The replacement insulin acts in the same way as natural insulin, and helps glucose from the blood to enter cells.
Bulgarian: De vervangende insuline werkt op dezelfde wijze als natuurlijke insuline en helpt bij de opname van glucose uit het bloed in de cellen.
English: Ryzodeg is used to treat diabetes in adults, adolescents and children from 2 years of age.
Bulgarian: Ryzodeg wordt gebruikt voor de behandeling van diabetes bij volwassenen, jongeren en kinderen ouder dan twee jaar.
English: The most frequently reported side effect during treatment with Ryzodeg is hypoglycaemia (low blood glucose levels).
Bulgarian: De meest gemelde bijwerking tijdens behandeling met Ryzodeg is hypoglykemie (lage bloedglucosespiegel).
English: 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.
Bulgarian: 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.
English: Why has Ryzodeg been approved?
Bulgarian: Waarom is Ryzodeg goedgekeurd?
English: Ryzodeg insulin degludec / insulin aspart
Bulgarian: Ryzodeg insuline degludec/insuline aspart
English: 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.
Bulgarian: 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.
English: Ryzodeg is a medicine that contains the active substances insulin degludec and insulin aspart.
Bulgarian: Ryzodeg is een geneesmiddel dat de werkzame stoffen insuline degludec en insuline aspart bevat.
English: Ryzodeg is a replacement insulin for the insulin normally made by the body.
Bulgarian: Ryzodeg is een insulineanaloog, een vervanger voor de normaliter door het lichaam aangemaakte insuline.
English: The CHMP concluded that Ryzodeg is effective in controlling blood glucose levels in adults, adolescents and children aged over 2 years with diabetes.
Bulgarian: 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.
English: The full EPAR for Ryzodeg can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Bulgarian: 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.
English: Ryzodeg has also been studied in one main study in 362 children aged between 1 and 17 years with type 1 diabetes.
Bulgarian: Ryzodeg is ook onderzocht in een hoofdstudie onder 362 kinderen in de leeftijd van 1
English: What is the risk associated with Ryzodeg?
Bulgarian: Welke risico's houdt het gebruik van Ryzodeg in?
English: 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.
Bulgarian: Diabetes is een ziekte waarbij het lichaam niet voldoende insuline produceert om de bloedsuikerspiegel
English: Insulin degludec and insulin aspart are slightly different from human insulin.
Bulgarian: Insuline degludec en insuline aspart verschillen slechts in geringe mate van humane insuline.
English: How has Ryzodeg been studied?
Bulgarian: Hoe is Ryzodeg onderzocht?
English: 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.
Bulgarian: te reguleren tot aan de volgende dosis, evenals kortwerkende insuline om de extra suiker uit de maaltijd te helpen verwerken.
English: How is Ryzodeg used?
Bulgarian: Hoe wordt Ryzodeg gebruikt?
English: All of the studies measured the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood attached to glucose.
Bulgarian: In alle studies werd de spiegel van geglycosyleerde hemoglobine (HbA1c) gemeten.
English: How does Ryzodeg work?
Bulgarian: Hoe werkt Ryzodeg?
English: 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.
Bulgarian: De injectieplaats moet bij elke injectie worden gewisseld om de kans op vorming van onderhuidse vetbulten
English: In type 1 diabetes, Ryzodeg is used with rapid-acting insulin, which is injected at other mealtimes.
Bulgarian: samen met een snelwerkende insuline, die bij andere maaltijden wordt geïnjecteerd.
English: In the studies in type 1 diabetes, patients also received injections of rapid acting insulin at other mealtimes.
Bulgarian: In de studies naar diabetes type 1 kregen de patiënten ook injecties met
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 Ryzodeg.
Bulgarian: Het geeft uitleg over de aanpak van het Comité voor geneesmiddelen voor menselijk gebruik (CHMP) bij de beoordeling van het geneesmiddel, een proces dat
English: 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.
Bulgarian: Deze behandeling werd vergeleken met een behandeling waarbij insuline detemir een- of tweemaal daags werd toegediend en insuline aspart bij alle maaltijden.
English: Meanwhile, insulin aspart is absorbed faster by the body than human insulin, and therefore it starts to work as soon as it is injected and has a short duration of action.
Bulgarian: Daarentegen wordt insuline aspart sneller door het lichaam opgenomen dan humane insuline.
English: In the study in children, the combined used of Ryzodeg and insulin aspart was at least as effective as insulin detemir and insulin aspart, with average HbA1c reductions of 0.27 and 0.23 percentage points respectively.
Bulgarian: Uit de studies onder volwassenen bleek dat Ryzodeg minstens even werkzaam was als langwerkende insulines en bifasische insuline wat betreft het reguleren van de bloedglucosespiegel bij patiënten met diabetes type 1 en type 2. De verlaging van de HbA1c-spiegel (in procentpunten) bedroeg 0,7 bij patiënten met diabetes type 1 en varieerde van 1 tot 1,7 in de studies bij patiënten met diabetes type 2. In de studie onder kinderen bleek het gecombineerde gebruik van Ryzodeg en insuline aspart minstens even werkzaam als insuline detemir en insuline aspart, met een gemiddelde verlaging van de HbA1c-spiegel met 0,27 respectievelijk 0,23 procentpunten.
English: Ryzodeg has been studied in one main study involving 548 adults with type 1 diabetes and in four main studies involving 1,866 adults with type 2 diabetes.
Bulgarian: Ryzodeg is onderzocht in een hoofdstudie met 548 patiënten met diabetes type 1 en in vier hoofdstudies met 1 866 patiënten met diabetes type 2. In de studies werd bij de maaltijd toegediend Ryzodeg vergeleken met insuline glargine of insuline detemir (langwerkende insulines), dan wel met bifasische insuline (een insulineformulering die bestaat uit een mengsel van middellangwerkende en snelwerkende insuline).
English: By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.
Bulgarian: Regulering van de bloedglucosespiegel vermindert de symptomen en complicaties van diabetes. Door Ryzodeg bij een hoofdmaaltijd te injecteren komt langwerkende insuline beschikbaar om de bloedsuiker
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Bulgarian: ime Jakost Farmacevtska oblika Pot uporabe Stična ovojnina
English: Immediate Packaging Pack size
Bulgarian: HDPE vsebnik
English: Dehydration may be a contributing factor in some of these cases.
Bulgarian: Дехидратацията може да е допринасящ фактор при някои от тези случаи.
English: However, these conditions are reported more frequently in the younger children in general.
Bulgarian: Като цяло обаче, тези състояния са съобщавани по-често при по-малките деца.
English: Long term safety data is not available.
Bulgarian: Дългосрочни данни за безопасността не са налични.
English: This effect is considered clinically not relevant.
Bulgarian: Счита се, че този ефект не е клинично значим.
English: Your dose of Translarna depends on your body weight.
Bulgarian: Вашата доза Translarna зависи от Вашето телесно тегло.
English: There have been cases reported where this increase to abnormal high values was already observed after 4 weeks.
Bulgarian: Съобщени са случаи, при които това повишение до необичайно високи стойности е наблюдавано вече след 4 седмици.
English: Other medicines and Translarna
Bulgarian: Други лекарства и Translarna
English: Characteristic in specific groups of subjects or patients
Bulgarian: Характеристики при специфични групи участници или пациенти
English: A standard package of reproduction toxicity studies was available.
Bulgarian: Наличен е стандартния пакет проучвания на репродуктивната токсичност.
English: Patients should take the entire dose.
Bulgarian: Пациентите трябва да приемат цялата доза.
English: Your doctor or pharmacist will tell you the exact number of sachets and what strength to take at each time.
Bulgarian: Вашият лекар или фармацевт ще Ви каже точния брой сашета и каква концентрация да приемате всеки път.
English: adefovir treatment of chronic hepatitis B and/or HIV
Bulgarian: адефовир лечение на хроничен хепатит B и/или HIV
English: Date of first authorisation: 31 July 2014 Date of latest renewal: 19 July 2018
Bulgarian: Дата на първо разрешаване: 31 юли 2014 г.
English: Delayed or missed dose
Bulgarian: Забавена или пропусната доза
English: It is important to take the correct dose.
Bulgarian: Важно е да се прилага правилната доза.
English: What Translarna is and what it is used for 2.
Bulgarian: Какво представлява Translarna и за какво се използва 2.
English: You may have one or more of the following side effects after taking Translarna:
Bulgarian: Възможно е да получите една или повече от следните нежелани реакции след прием на Translarna:
English: These may affect your kidney function.
Bulgarian: Те могат да засегнат Вашите бъбречни функции.
English: Tell your doctor if you are taking any of the following medicines:
Bulgarian: Уведомете Вашия лекар, ако приемате някое от следните лекарства:
English: Do not stop taking Translarna without talking to your doctor.
Bulgarian: Не трябва да спирате приема на Translarna, без да сте говорили с Вашия лекар.
English: Frequency groupings are defined to the following convention: very common (≥ 1/10) and common (≥ 1/100 to < 1/10).
Bulgarian: Групирането по честота е определено съгласно следната конвенция: много чести (≥ 1/10) и чести (≥ 1/100 до < 1/10).
English: Do not give this medicine to children under the age of 2 years or weighing less than 12 kg as it has not been tested in this group of patients.
Bulgarian: Това лекарство не трябва да се дава на деца на възраст под 2 години или с тегло по-малко от 12 kg, тъй като не е изследвано при тази група пациенти.
English: Potential interactions with other medicinal products
Bulgarian: Потенциални взаимодействия с други лекарствени продукти
English: Your doctor will monitor your blood pressure every 6 months, if you are taking a corticosteroid medicine.
Bulgarian: Вашият лекар ще следи кръвното Ви налягане на всеки 6 месеца, ако приемате кортикостероидно лекарство.
English: Ataluren does not distribute into red blood cells.
Bulgarian: Аталурен не се разпределя в червените кръвни клетки.
English: No serious adverse reactions were observed in these subjects.
Bulgarian: При тези участници не са наблюдавани сериозни нежелани реакции.
English: A risk to the breastfed new-borns/infants cannot be excluded.
Bulgarian: Рискът за новороденото/бебето не може да се изключи.
English: Open the sachet only at the time you are taking the medicine and use the entire amount from the sachet.
Bulgarian: Отваряйте сашето само в момента, в който приемате лекарството, и използвайте цялото количество от сашето.
English: In the event of a suspected overdose, supportive medical care should be provided including consulting with a healthcare professional and close observation of the clinical status of the patient.
Bulgarian: В случай на подозрения за предозиране, трябва да се осигури поддържаща медицинска грижа, включително консултация със здравен специалист и внимателно наблюдение на клиничното състояние на пациента.
English: Changes in lipid profile
Bulgarian: Промени в липидния профил
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Bulgarian: Изискванията за подаване на периодични актуализирани доклади за безопасност за този лекарствен продукт, са посочени в списъка с референтните дати на Европейския съюз (EURD списък), предвиден в чл. 107в, ал.7 от Директива 2001/83/ЕО, и във всички следващи актуализации, публикувани на европейския уебпортал за лекарства.
English: Patients who do not have a nonsense mutation
Bulgarian: Пациенти, които нямат безсмисленa мутация
English: The safety and efficacy of Translarna in children <12kg and aged 6 months to 2 years have not yet been established.
Bulgarian: Безопасността и ефикасността на Translarna при деца <12 kg и на възраст от 6 месеца до 2 години все още не са установени.
English: Drink water or other liquids regularly to avoid dehydration while taking Translarna.
Bulgarian: Редовно пийте вода или други течности, за да избегнете обезводняване, докато приемате Translarna.
English: Translarna is available in packs containing 30 sachets.
Bulgarian: Translarna се предлага в опаковки, съдържащи 30 сашета.
English: Frequency not known
Bulgarian: Неизвестна честота
English: Translarna may not be as effective in treating your symptoms if you take more than the recommended dose.
Bulgarian: Възможно е Translarna да не е толкова ефективен за лечение на Вашите симптоми, ако приемате по-голяма доза препоръчителната.
English: The significance of these findings for humans is unknown.
Bulgarian: Значението на тези находки при хора не е известно.
English: Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Bulgarian: Информирайте Вашия лекар, ако приемате, наскоро сте приемали или е възможно да приемате други лекарства.
English: Patients should not take a double or extra dose if a dose is missed.
Bulgarian: Пациентите не трябва да приемат двойна или допълнителна доза, ако са пропуснали една доза.
English: For example, you might take Translarna at 7:00 AM in the morning with breakfast, at 1:00 PM in the afternoon with lunch, and again at around 7:00 PM in the evening with dinner.
Bulgarian: Например може да приемете Translarna в 7:00 часа сутринта със закуска, в 1:00 часа следобед с обяд и отново около 7:00 часа вечерта с вечеря.
English: Name and address of the manufacturer responsible for batch release Almac Pharma Services Ltd.
Bulgarian: Име и адрес на производителя, отговорен за освобождаване на партидите Almac Pharma Services Ltd.
English: If you have any kidney problem, your doctor should check your kidney function regularly.
Bulgarian: Ако имате някакви проблеми с бъбреците, Вашият лекар трябва редовно да проверява бъбречните Ви функции.
English: Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate Dundalk, Co. Louth, A91 P9KD Ireland
Bulgarian: Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate Dundalk, Co. Louth, A91 P9KD Ирландия
English: The pharmacokinetics of ataluren has been evaluated in study PTC124-GD-030 over a duration of 4 weeks.
Bulgarian: Фармакокинетиката на аталурен е оценена в проучване PTC124-GD-030 с продължителност 4 седмици.
English: Separation between ataluren and placebo was maintained from Week 16 through the end of the study.
Bulgarian: Разликата между аталурен и плацебо се поддържа от седмица 16 до края на проучването.
English: The efficacy of Translarna in children aged 2 - 5 years has been established on extrapolation from patients aged >5years.
Bulgarian: Ефикасността на Translarna при деца на възраст 2 - 5 години е установена при екстраполация от пациенти на възраст >5 години.
English: You or your child will have been tested by your doctor before starting treatment with Translarna, in order to confirm that your disease is suitable for treatment with this medicine.
Bulgarian: Вие или Вашето дете ще бъдете изследвани от Вашия лекар преди начало на лечението с Translarna, за да се потвърди, че е подходящо Вашата болест да се лекува с това лекарство.
English: Your doctor must have done a blood test to confirm that your disease is suitable for treatment with Translarna.
Bulgarian: Вашият лекар трябва да направи кръвно изследване, за да потвърди, че е подходящо Вашата болест да се лекува с Translarna.
English: The significance for humans is not known.
Bulgarian: Не е известно значението за хората.
English: Pyrexia, weight decreased
Bulgarian: Пирексия, намаляване на теглото
English: Contact your doctor if you take more than the recommended dose of Translarna.
Bulgarian: Свържете се с Вашия лекар, ако приемете повече от препоръчителната доза Translarna.
English: Remember to take the next dose on time.
Bulgarian: Помнете, че трябва да приемете следващата доза навреме.
English: Take Translarna by mouth 3 times per day; in the morning, midday and evening.
Bulgarian: Translarna се приема през устата 3 пъти дневно - сутрин, обед и вечер.