FrancophonIA/ELRC3.0 huggingface dataset:
English: How to store Febuxostat Mylan
Bulgarian: Фебуксостат Mylan
English: SUN
Bulgarian: Пол
English: TUE
Bulgarian: Едем
English: Based on modelling and simulation analysis of data from a pre-clinical study in rats, when coadministered with febuxostat, the dose of mercaptopurine/azathioprine should be reduced to the 20% or less of the previously prescribed dose in order to avoid possible haematological effects (see section 4.5 and 5.3).
Bulgarian: Въз основа на моделиране и симулационен анализ на данни от предклинично проучване при плъхове, при едновременното приложение с фебуксостат, дозата на меркаптопурин/азатиоприн трябва да се намали до 20% или по-малко от предходната предписана доза, за да се избегнат възможни хематологични ефекти (вж. точка 4.5).
English: Endocrine disorders
Bulgarian: Нарушения на ендокринната система
English: Allopurinol
Bulgarian: Tеофилин
English: sections)
Bulgarian: УКАЗАНИЯ
English: LABELLING AND PACKAGE LEAFLET
Bulgarian: Вид и съдържание на опаковката
English: EU/1/17/1194/014 EU/1/17/1194/015 EU/1/17/1194/016 EU/1/17/1194/023 EU/1/17/1194/024 EU/1/17/1194/025 EU/1/17/1194/026 EU/1/17/1194/027 EU/1/17/1194/028
Bulgarian: EU/1/17/1194/009 EU/1/17/1194/010 EU/1/17/1194/011 EU/1/17/1194/012 EU/1/17/1194/013 EU/1/17/1194/014 EU/1/17/1194/015 EU/1/17/1194/016 EU/1/17/1194/023 EU/1/17/1194/024 EU/1/17/1194/025 EU/1/17/1194/026 EU/1/17/1194/027 EU/1/17/1194/028
English: What Febuxostat Mylan contains
Bulgarian: Фебуксостат Mylan:
English: EU/1/17/1194/007 EU/1/17/1194/008 EU/1/17/1194/017 EU/1/17/1194/018 EU/1/17/1194/019 EU/1/17/1194/020 EU/1/17/1194/021 EU/1/17/1194/022
Bulgarian: EU/1/17/1194/001 EU/1/17/1194/002 EU/1/17/1194/003 EU/1/17/1194/004 EU/1/17/1194/005 EU/1/17/1194/006 EU/1/17/1194/007 EU/1/17/1194/008 EU/1/17/1194/017 EU/1/17/1194/018 EU/1/17/1194/019 EU/1/17/1194/020 EU/1/17/1194/021 EU/1/17/1194/022
English: Tabulated list of adverse reactions
Bulgarian: Нежелани реакции в табличен вид
English: Excipients
Bulgarian: ПРИТЕЖАТЕЛ
English: Fatigue, chest pain, chest discomfort Rare
Bulgarian: Умора, едем, болка в гърдите, усещане на дискомфорт в гръдния кош
English: Liver function abnormalities** Uncommon
Bulgarian: Стомашно-чревни нарушения Чести Диария**, гадене
English: Target species
Bulgarian: Ciljna živalska vrsta
English: Strength Pharmaceutical form
Bulgarian: Jakost Farmacevtska oblika
English: Packaging
Bulgarian: Ovojnina
English: Content Package size
Bulgarian: Vsebina Velikost pakiranja Karenca
English: Invented name
Bulgarian: EU številka Izmišljeno
English: Route of administration
Bulgarian: Način uporabe zdravila
English: • organ transplantation.
Bulgarian: органна трансплантация.
English: The European Commission issued a decision on 5 September 2013.
Bulgarian: Европейската комисия издава решение на 05 септември 2013 г.
English: The company wanted the authorisation to be recognised in Germany and the Netherlands (the ‘concerned Member States').
Bulgarian: Фирмата иска разрешението за употреба да бъде признато в Германия и Нидерландия („засегнати държави членки“).
English: • allergies, including severe allergic reactions;
Bulgarian: алергии, включително тежки алергични реакции;
English: What is Okrido?
Bulgarian: Какво представлява Okrido?
English: 5 September 2013
Bulgarian: 05 септември 2013 г.
English: In particular, as the two medicines contain different excipients (inactive ingredients), the Netherlands considered that further studies were needed to show that these differences did not result in relevant differences in the way the two medicines are absorbed by the body.
Bulgarian: По-специално, тъй като двете лекарства съдържат различни помощни вещества (неактивни съставки), Нидерландия счита, че са необходими допълнителни проучвания, за да бъде доказано, че тези разлики не водят до значителни различия в начините, по които двете лекарства се абсорбират от тялото.
English: It is available as an oral solution (6mg/ml).
Bulgarian: Той се предлага под формата на перорален разтвор (6 mg/ml).
English: Okrido is used to treat a range of inflammatory and auto-immune conditions (diseases caused by the body's own defence system attacking normal tissue) including:
Bulgarian: Okrido се използва за лечение на диапазон от възпалителни и автоимунни заболявания (заболявания, причинени от собствената защитна система на тялото, която атакува нормалната тъкан), включително:
English: • some cancers, including leukaemia, lymphoma and myeloma;
Bulgarian: някои видове рак, включително левкемия, лимфом и миелом;
English: Based on an evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that, based on the data submitted, Okrido is expected to produce comparable levels of the active substance in the body to the reference medicine.
Bulgarian: Въз основа на оценката на наличните към момента данни и научното обсъждане в рамките на Комитета, CHMP заключи, че въз основа на подадените данни се очаква Okrido да произвежда сравними нива на активното вещество в тялото, като тези на референтното лекарство.
English: Why was Okrido reviewed?
Bulgarian: Какви са основанията за преразглеждане на Okrido?
English: Pharmapol Arzneimittelvertrieb GmbH submitted Okrido for mutual recognition on the basis of the initial authorisation granted by the United Kingdom's Medicines and Healthcare products Regulatory Agency on 19 April 2010.
Bulgarian: На 19 април 2010 г. Pharmapol Arzneimittelvertrieb GmbH подава заявление за взаимно признаване на Okrido въз основа на първоначалното разрешение за употреба, издадено от Британската регулаторна агенция по лекарствата и здравните продукти.
English: The active substance in Okrido, prednisolone sodium phosphate, belongs to a group of medicines called glucocorticoids, which are substances that help to reduce inflammation.
Bulgarian: Активното вещество в Okrido, преднизолон натриев фосфат, принадлежи към група лекарства, наречени глюкокортикоиди, които помагат за намаляване на възпаленията.
English: On 27 June 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Okrido.
Bulgarian: Европейската агенция по лекарствата завършва арбитражна процедура вследствие на несъгласие между държавите членки на Европейския съюз (ЕС) относно разрешението за употреба на лекарствения продукт Okrido.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Okrido outweighs its risks, and the marketing authorisation granted in the United Kingdom can be recognised in other Member States of the EU.
Bulgarian: Комитетът по лекарствените продукти за хуманна употреба (CHMP) на Агенцията заключи, че ползите от Okrido надвишават рисковете и разрешението за употреба, издадено в Обединеното кралство, може да бъде признато в другите държави членки на ЕС.
English: Okrido is a generic medicine based on a ‘reference medicine' already authorised in the EU.
Bulgarian: Okrido е генерично лекарство, основано на „референтното лекарство“, което е разрешено за употреба във всички държави членки на ЕС.
English: Okrido is a medicine that contains the active substance prednisolone sodium phosphate.
Bulgarian: Okrido е лекарствен продукт, който съдържа активното вещество преднизолон натриев фосфат (prednisolone sodium phosphate).
English: The reference medicine was Prednisolone 5 mg soluble tablets by Sovereign.
Bulgarian: Референтното лекарство е Prednisolone 5 mg разтворими таблетки на Sovereign.
English: • skin conditions;
Bulgarian: кожни заболявания;
English: The grounds for the referral were that sufficient data had not been provided to show that Okrido produces comparable levels of the active substance in the body to Prednisolone 5 mg soluble tablets by Sovereign.
Bulgarian: Основанията за сезирането са, че няма предоставени достатъчно данни, които да показват, че Okrido произвежда в тялото нива на активното вещество, сравними с Prednisolone 5 mg разтворими таблетки на Sovereign.
English: • diseases of the lungs (including asthma), upper airways (croup), blood vessels and heart, bowel or kidneys, muscles and joints (including rheumatoid arthritis) or the eye or nervous system;
Bulgarian: кръвоносните съдове и сърцето, червата, бъбреците, мускулите и ставите (включително ревматоиден артрит), очите и нервната система;
English: The CHMP therefore concluded that the benefits of Okrido outweigh its risks, and therefore the marketing authorisation for Okrido should be granted in all concerned Member States.
Bulgarian: Поради това CHMP заключи, че ползите от Okrido са по-големи от рисковете и препоръча да се издаде разрешение за употреба в засегнатите държави членки.
English: However, the Member States were not able to reach an agreement and the United Kingdom referred the matter to the CHMP for arbitration on 5 March 2013.
Bulgarian: Въпреки това държавите членки не успяват да постигнат съгласие и на 05 март 2013 г.
English: In very rare cases, they may be serious or fatal.
Bulgarian: Dans de très rares cas, ils peuvent cependant être graves ou mortels.
English: What is the withdrawal period in food-producing animals?
Bulgarian: Quel est le temps d'attente chez les animaux producteurs d'aliments?
English: For the full list of restrictions, see the package leaflet.
Bulgarian: Pour une liste complète des restrictions, voir la notice.
English: A temporary swelling at the injection site can occur but resolves without intervention.
Bulgarian: Un gonflement temporaire au site d'injection peut se produire, mais disparaît sans intervention.
English: Other information about Metacam
Bulgarian: Autres informations relatives à Metacam
English: Metacam received a marketing authorisation valid throughout the EU for Metacam on 7 January 1998.
Bulgarian: Metacam a reçu une autorisation de mise sur le marché valide dans toute l'Union européenne le 7 janvier 1998.
English: The European Medicines Agency decided that Metacam's benefits are greater than its risks and that it can be authorised for use in the EU.
Bulgarian: L'Agence européenne des médicaments a estimé que les bénéfices de Metacam sont supérieurs à ses risques et que son utilisation peut être autorisée au sein de l'UE.
English: What are the precautions for the person who gives the medicine or comes into contact with the animal?
Bulgarian: Quelles sont les précautions à prendre par la personne qui administre le médicament ou entre en contact avec l'animal?
English: All sows also received antibiotics.
Bulgarian: Toutes les truies ont également reçu des antibiotiques.
English: The withdrawal period for meat is 5 days.
Bulgarian: Le temps d'attente pour la viande est de 5 jours.
English: For further information about using Metacam, see the package leaflet or contact your veterinarian or pharmacist.
Bulgarian: Pour plus d'informations sur l'utilisation de Metacam, voir la notice ou contacter votre vétérinaire ou votre pharmacien.
English: Metacam (meloxicam)
Bulgarian: Metacam (méloxicam)
English: People who are hypersensitive (allergic) to NSAIDs should avoid contact with Metacam.
Bulgarian: Les personnes présentant une hypersensibilité (allergie) aux AINS doivent éviter tout contact avec Metacam.
English: An overview of Metacam and why it is authorised in the EU
Bulgarian: Aperçu de Metacam et pourquoi il est autorisé dans l'UE
English: What benefits of Metacam have been shown in studies?
Bulgarian: Quels sont les bénéfices de Metacam démontrés au cours des études?
English: It is also the time required after administration of a medicine before milk may be used for human consumption.
Bulgarian: Il s'agit également du délai à observer après l'administration d'un médicament avant que le lait puisse être utilisé pour la consommation humaine.
English: The withdrawal period is 15 days for meat and 5 days for milk.
Bulgarian: Le temps d'attente est de 15 jours pour la viande et de 5 jours pour le lait.
English: What are the risks associated with Metacam?
Bulgarian: Quels sont les risques associés à l'utilisation de Metacam?
English: In cattle, pigs and horses in very rare cases anaphylactoid reactions which may be serious (including fatal) may occur and should be treated symptomatically.
Bulgarian: Chez les bovins, les porcins et les chevaux, des réactions anaphylactoïdes qui peuvent être graves (y compris mortelles) peuvent survenir dans de très rares cas et doivent faire l'objet d'un traitement symptomatique.
English: Metacam is an anti-inflammatory medicine used in cattle, pigs, horses, dogs, cats and guinea pigs.
Bulgarian: Metacam est un médicament anti-inflammatoire utilisé chez les bovins, les porcins, les chevaux, les chiens, les chats et les cochons d'Inde.
English: Why is Metacam approved in the EU?
Bulgarian: Pourquoi Metacam est-il autorisé dans l'UE?
English: Further information on Metacam can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Bulgarian: De plus amples informations sur Metacam sont disponibles sur le site web de l'Agence, sous: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. Dernière mise à jour du présent aperçu: mars 2018.
English: The main measure of effectiveness was the assessment of pain score at various time points up to 20 hours post-surgery.
Bulgarian: Le principal critère d'évaluation de l'efficacité était l'appréciation du score en matière de douleur à certains moments dans le temps, jusqu'à 20 heures après l'intervention chirurgicale.
English: The 40 mg/ml solution for injection should not be handled by pregnant women or women attempting to conceive as accidental self-injection may affect the development of the baby in the womb.
Bulgarian: La solution injectable à 40 mg/ml ne doit pas être manipulée par les femmes enceintes ou tentant de concevoir un enfant, étant donné qu'une auto-injection accidentelle peut affecter le développement du bébé dans l'utérus.
English: Metacam contains the active substance meloxicam.
Bulgarian: Metacam contient le principe actif méloxicam.
English: Metacam can only be obtained with a prescription.
Bulgarian: Metacam n'est délivré que sur ordonnance.
English: If the product is accidentally swallowed or self-injected by a person, the advice of a doctor should be sought immediately.
Bulgarian: En cas d'ingestion ou d'auto-injection accidentelles, il convient de consulter immédiatement un médecin.
English: 37 cats received Metacam and 39 cats received carprofen (another NSAID) by subcutaneous (under the skin) injection immediately after receiving anaesthesia.
Bulgarian: 37 chattes ont reçu Metacam et 39 du carprofène (un autre AINS) par injection sous-cutanée (sous la peau) immédiatement après avoir reçu un anesthésique.
English: Both medicines were comparable in reducing pain associated with equine colic.
Bulgarian: L'efficacité des deux médicaments s'est révélée comparable pour réduire la douleur associée à la colique équine.
English: How is Metacam used?
Bulgarian: Comment Metacam est-il utilisé?
English: Metacam was comparable to flunixin in treating signs of infection and inflammation associated with puerperal septicaemia and toxaemia.
Bulgarian: Metacam s'est révélé comparable à flunixine pour le traitement des signes d'infection et d'inflammation liés à une septicémie puerpérale et à une toxémie.
English: Metacam significantly reduced lameness with 49% of the Metacam treated pigs with no lameness compared with 27% of the pigs which received the placebo treatment.
Bulgarian: Metacam a réduit de manière significative la claudication, 49 % des porcins traités par Metacam ne présentant aucune claudication, contre 27 % de ceux ayant reçu le placebo.
English: What is Metacam and what is it used for?
Bulgarian: Qu'est-ce que Metacam et dans quel cas est-il utilisé?
English: A study in 187 sows with puerperal septicaemia and toxaemia compared Metacam with flunixin (another NSAID).
Bulgarian: Une étude portant sur 187 truies présentant une septicémie puerpérale et une toxémie a comparé Metacam avec la flunixine (un autre AINS).
English: In very rare cases loss of appetite, lethargy, abdominal pain and colitis (inflammation of the lower part of the gut) have been reported.
Bulgarian: Dans de très rares cas, une perte d'appétit, une léthargie, des douleurs abdominales et une colite (inflammation de la partie inférieure de l'intestin) ont été signalées.
English: The withdrawal period is the time allowed after administration of the medicine before an animal can be slaughtered and the meat used for human consumption.
Bulgarian: Le temps d'attente est la durée requise entre l'administration d'un médicament et le moment où un animal peut être abattu et la viande utilisée pour la consommation humaine.
English: The main measure of effectiveness was blood levels of the stress hormone cortisol 30 minutes after surgery.
Bulgarian: Le principal critère d'évaluation de l'efficacité était le taux de cortisol (hormone du stress) dans le sang, 30 minutes après l'intervention chirurgicale.
English: Metacam injection was studied in 76 cats undergoing ovariohysterectomy.
Bulgarian: Metacam solution injectable a été étudiée chez 76 chattes subissant une ovariohystérectomie.
English: 46 cats received Metacam oral suspension for 28 days whilst 48 cats received placebo oral suspension.
Bulgarian: été réalisée sur des chats atteints de troubles musculo-squelettiques chroniques. 46 chats ont reçu Metacam suspension orale pendant 28 jours, tandis que 48 chats ont reçu le placebo sous la forme de suspension orale.
English: Metacam injection was compared with vedaprofen (another NSAID) for pain relief associated with equine colic in 269 horses.
Bulgarian: Metacam solution injectable a été comparé au védaprofène (un autre AINS) dans le soulagement de la douleur associée à la colique équine chez 269 chevaux.
English: For the 20 mg/ml and 40 mg/ml solution for injection the meat withdrawal period is 5 days and for the 15 mg/ml oral suspension it is 3 days.
Bulgarian: Le temps d'attente pour la viande est de 5 jours pour la solution injectable à 20 mg/ml et à 40 mg/ml, et de 3 jours pour la suspension orale à 15 mg/ml. Le médicament n'est pas autorisé pour un usage chez les juments produisant du lait pour la consommation humaine.
English: In dogs and cats, occasional side effects of Metacam are those seen with NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools, apathy (lack of vitality) and kidney failure.
Bulgarian: Chez les chiens et les chats, les effets indésirables occasionnels de Metacam sont ceux observés avec les AINS, notamment perte d'appétit, vomissements, diarrhée, sang dans les selles, apathie (absence de vitalité) et insuffisance rénale.
English: A study in 150 piglets was carried out to compare the effects of Metacam injection with placebo when given before castration.
Bulgarian: sur 150 porcelets a été menée afin de comparer les effets de Metacam solution injectable avec ceux du placebo lorsque ces produits sont administrés avant la castration.
English: Calves treated with Metacam showed a significant improvement in their signs of diarrhoea compared with the control group.
Bulgarian: traités par Metacam ont présenté une amélioration significative de leurs signes de diarrhée.
English: Metacam treated piglets had significantly reduced blood cortisol levels (which indicates that they were exposed to lower levels of stress) 30 minutes after castration compared with the control group.
Bulgarian: Par comparaison avec le groupe témoin, les porcelets traités par Metacam présentaient des taux considérablement inférieurs de cortisol dans le sang (ce qui indique qu'ils ont été exposés à de niveaux de stress inférieurs), 30 minutes après la castration.
English: Animals received either Metacam injection or a placebo injection.
Bulgarian: ont reçu soit Metacam solution injectable, soit une injection de placebo.
English: Horses
Bulgarian: Chevaux
English: The effectiveness of Metacam injection, in combination with antibiotic therapy, was studied in cattle with acute respiratory infection.
Bulgarian: L'efficacité de Metacam solution injectable, administrée en association avec un traitement par antibiotiques, a été étudiée chez les bovins présentant une infection respiratoire aiguë.
English: Another study in cattle involved 501 calves with diarrhoea.
Bulgarian: Une autre étude a été menée sur 501 veaux
English: Metacam 5 mg/ml solution for injection was comparable to carprofen in reducing post-operative pain in cats following ovariohysterectomy.
Bulgarian: L'efficacité de Metacam solution injectable à 5 mg/ml s'est révélée comparable à celle du carprofène pour réduire la douleur postopératoire chez les chattes ayant
English: Metacam oral suspension was studied for treatment of musculoskeletal disorders associated with lameness in two studies and compared to treatment with vedaprofen.
Bulgarian: Le traitement par Metacam suspension orale de troubles musculo-squelettiques associés à une claudication a fait l'objet de deux études et a été comparé au traitement par védaprofène.
English: In horses, Metacam is used to relieve pain associated with colic (abdominal pain) and to alleviate inflammation and pain in both acute and chronic (long-term) musculo-skeletal disorders (disorders affecting the muscles and bones).
Bulgarian: Chez les chevaux, Metacam est utilisé pour soulager la douleur associée à la colique (douleurs abdominales) et pour soulager l'inflammation et la douleur dans les troubles musculosquelettiques (troubles affectant les muscles et les os) aigus ou chroniques (à long terme).
English: The study showed that the dogs receiving meloxicam injection followed by oral doses had the best results in improving mobility based on a standard scoring system.
Bulgarian: Dans une étude, une comparaison a été effectuée entre trois schémas de traitement par méloxicam différents pour les troubles locomoteurs aigus. Cette étude a montré que les chiens recevant une injection de méloxicam suivie de doses orales présentaient les meilleurs résultats en termes d'amélioration de la mobilité, mesurés à l'aide d'un système standard d'évaluation.
English: In addition slight urticaria (itchy rash) and diarrhoea can occur which are both typical side effects of NSAIDs and which resolve by themselves.
Bulgarian: De plus, une urticaire légère (éruption cutanée avec démangeaisons) et une diarrhée peuvent se produire; il s'agit de deux effets indésirables caractéristiques des AINS qui disparaissent spontanément.
English: In guinea pigs, Metacam is used to reduce post-operative pain after soft tissue surgery such as castration.
Bulgarian: Chez les cochons d'Inde, Metacam est utilisé pour réduire la douleur postopératoire suivant une chirurgie des tissus mous, telle que la castration.
English: In cattle, Metacam is used together with antibiotics, to reduce clinical signs such as fever and inflammation in acute (short-term) respiratory infection (infection of the lungs and airways).
Bulgarian: Chez les bovins, Metacam est utilisé en association avec des antibiotiques, afin de réduire les signes cliniques de l'infection respiratoire (infection des poumons et des voies aériennes) aiguë (passagère), tels que la fièvre et l'inflammation.
English: Guinea pigs treated with Metacam had significantly higher frequency of feed intake (240 events) over three days, indicating that their pain was reduced, compared with guinea pigs given placebo (207 events).
Bulgarian: sur 30 cochons d'Inde a comparé Metacam suspension orale à un placebo administré environ 45 minutes avant la castration chirurgicale et pendant les deux jours suivants. Les cochons d'Indes sous Metacam présentaient une fréquence de consommation d'aliments significativement supérieure (240 événements) sur trois jours, ce qui indique que leur douleur était réduite, par comparaison avec les cochons d'Inde sous placebo (207 événements).
English: Metacam injection in combination with antibiotic therapy was investigated in a study involving 240 cattle with acute mastitis.
Bulgarian: Metacam solution injectable associée à un traitement par antibiotiques a été examinée dans le cadre d'une étude portant sur 240 bovins présentant une mammite aiguë.
English: Guinea pigs
Bulgarian: Cochons d'Inde