natgillin/translations-raw huggingface dataset:
Фармакокинетично моделиране и симулация на данни от плъхове предполагат, че при едновременно приложение с фебуксостат, клиничната доза 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 4.4 и 4.5). 
Pharmacokinetic modelling and simulation of rat data suggests that, when co-administered with febuxostat, the clinical dose of mercaptopurine/azathioprine should be reduced to 20% or less of the previously prescribed dose in order to avoid possible haematological effects (see section 4.4 and 4.5).
Вт 
Gout
Фебуксостат Mylan 120 mg филмирани таблетки фебуксостат 
Febuxostat Mylan 120 mg film-coated tablets febuxostat
Mylan Hrvatska d.o.o. Tel: +385 1 23 50 599 
Mylan Healthcare d.o.o Tel: + 386 1 23 63 180
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 и 5.3). 
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).
Фебуксостат Mylan 
How to store Febuxostat Mylan
Пол 
SUN
Едем 
TUE
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). 
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).
Нарушения на ендокринната система 
Endocrine disorders
Tеофилин 
Allopurinol
УКАЗАНИЯ 
sections)
Вид и съдържание на опаковката 
LABELLING AND PACKAGE LEAFLET
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 
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
Фебуксостат Mylan: 
What Febuxostat Mylan contains
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 
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
Нежелани реакции в табличен вид 
Tabulated list of adverse reactions
ПРИТЕЖАТЕЛ 
Excipients
Умора, едем, болка в гърдите, усещане на дискомфорт в гръдния кош 
Fatigue, chest pain, chest discomfort Rare
Стомашно-чревни нарушения Чести Диария**, гадене 
Liver function abnormalities** Uncommon
Ciljna živalska vrsta 
Target species
Jakost Farmacevtska oblika 
Strength Pharmaceutical form
Ovojnina 
Packaging
Vsebina Velikost pakiranja Karenca 
Content Package size
EU številka Izmišljeno 
Invented name
Način uporabe zdravila 
Route of administration
органна трансплантация. 
• organ transplantation.
Европейската комисия издава решение на 05 септември 2013 г. 
The European Commission issued a decision on 5 September 2013.
Фирмата иска разрешението за употреба да бъде признато в Германия и Нидерландия („засегнати държави членки“). 
The company wanted the authorisation to be recognised in Germany and the Netherlands (the ‘concerned Member States').
алергии, включително тежки алергични реакции; 
• allergies, including severe allergic reactions;
Какво представлява Okrido? 
What is Okrido?
05 септември 2013 г. 
5 September 2013
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. 
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.
Той се предлага под формата на перорален разтвор (6 mg/ml). 
It is available as an oral solution (6mg/ml).
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: 
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:
някои видове рак, включително левкемия, лимфом и миелом; 
• some cancers, including leukaemia, lymphoma and myeloma;
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. 
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.
Какви са основанията за преразглеждане на Okrido? 
Why was Okrido reviewed?
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. 
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.
Активното вещество в Okrido, преднизолон натриев фосфат, принадлежи към група лекарства, наречени глюкокортикоиди, които помагат за намаляване на възпаленията. 
The active substance in Okrido, prednisolone sodium phosphate, belongs to a group of medicines called glucocorticoids, which are substances that help to reduce inflammation.
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. 
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.
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. 
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.
Okrido е генерично лекарство, основано на „референтното лекарство“, което е разрешено за употреба във всички държави членки на ЕС. 
Okrido is a generic medicine based on a ‘reference medicine' already authorised in the EU.
Okrido е лекарствен продукт, който съдържа активното вещество преднизолон натриев фосфат (prednisolone sodium phosphate). 
Okrido is a medicine that contains the active substance prednisolone sodium phosphate.
Референтното лекарство е Prednisolone 5 mg разтворими таблетки на Sovereign. 
The reference medicine was Prednisolone 5 mg soluble tablets by Sovereign.
кожни заболявания; 
• skin conditions;
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. 
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.
кръвоносните съдове и сърцето, червата, бъбреците, мускулите и ставите (включително ревматоиден артрит), очите и нервната система; 
• 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;
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. 
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.
Въпреки това държавите членки не успяват да постигнат съгласие и на 05 март 2013 г. 
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.
Dans de très rares cas, ils peuvent cependant être graves ou mortels. 
In very rare cases, they may be serious or fatal.
Quel est le temps d'attente chez les animaux producteurs d'aliments? 
What is the withdrawal period in food-producing animals?
Pour une liste complète des restrictions, voir la notice. 
For the full list of restrictions, see the package leaflet.
Un gonflement temporaire au site d'injection peut se produire, mais disparaît sans intervention. 
A temporary swelling at the injection site can occur but resolves without intervention.
Autres informations relatives à Metacam 
Other information about Metacam
Metacam a reçu une autorisation de mise sur le marché valide dans toute l'Union européenne le 7 janvier 1998. 
Metacam received a marketing authorisation valid throughout the EU for Metacam on 7 January 1998.
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. 
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.
Quelles sont les précautions à prendre par la personne qui administre le médicament ou entre en contact avec l'animal? 
What are the precautions for the person who gives the medicine or comes into contact with the animal?
Toutes les truies ont également reçu des antibiotiques. 
All sows also received antibiotics.
Le temps d'attente pour la viande est de 5 jours. 
The withdrawal period for meat is 5 days.
Pour plus d'informations sur l'utilisation de Metacam, voir la notice ou contacter votre vétérinaire ou votre pharmacien. 
For further information about using Metacam, see the package leaflet or contact your veterinarian or pharmacist.
Metacam (méloxicam) 
Metacam (meloxicam)
Les personnes présentant une hypersensibilité (allergie) aux AINS doivent éviter tout contact avec Metacam. 
People who are hypersensitive (allergic) to NSAIDs should avoid contact with Metacam.
Aperçu de Metacam et pourquoi il est autorisé dans l'UE 
An overview of Metacam and why it is authorised in the EU
Quels sont les bénéfices de Metacam démontrés au cours des études? 
What benefits of Metacam have been shown in studies?
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. 
It is also the time required after administration of a medicine before milk may be used for human consumption.
Le temps d'attente est de 15 jours pour la viande et de 5 jours pour le lait. 
The withdrawal period is 15 days for meat and 5 days for milk.
Quels sont les risques associés à l'utilisation de Metacam? 
What are the risks associated with Metacam?
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. 
In cattle, pigs and horses in very rare cases anaphylactoid reactions which may be serious (including fatal) may occur and should be treated symptomatically.
Metacam est un médicament anti-inflammatoire utilisé chez les bovins, les porcins, les chevaux, les chiens, les chats et les cochons d'Inde. 
Metacam is an anti-inflammatory medicine used in cattle, pigs, horses, dogs, cats and guinea pigs.
Pourquoi Metacam est-il autorisé dans l'UE? 
Why is Metacam approved in the EU?
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. 
Further information on Metacam can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
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. 
The main measure of effectiveness was the assessment of pain score at various time points up to 20 hours post-surgery.
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. 
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.
Metacam contient le principe actif méloxicam. 
Metacam contains the active substance meloxicam.
Metacam n'est délivré que sur ordonnance. 
Metacam can only be obtained with a prescription.
En cas d'ingestion ou d'auto-injection accidentelles, il convient de consulter immédiatement un médecin. 
If the product is accidentally swallowed or self-injected by a person, the advice of a doctor should be sought immediately.
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. 
37 cats received Metacam and 39 cats received carprofen (another NSAID) by subcutaneous (under the skin) injection immediately after receiving anaesthesia.
L'efficacité des deux médicaments s'est révélée comparable pour réduire la douleur associée à la colique équine. 
Both medicines were comparable in reducing pain associated with equine colic.
Comment Metacam est-il utilisé? 
How is Metacam used?
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. 
Metacam was comparable to flunixin in treating signs of infection and inflammation associated with puerperal septicaemia and toxaemia.
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. 
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.
Qu'est-ce que Metacam et dans quel cas est-il utilisé? 
What is Metacam and what is it used for?
Une étude portant sur 187 truies présentant une septicémie puerpérale et une toxémie a comparé Metacam avec la flunixine (un autre AINS). 
A study in 187 sows with puerperal septicaemia and toxaemia compared Metacam with flunixin (another NSAID).
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. 
In very rare cases loss of appetite, lethargy, abdominal pain and colitis (inflammation of the lower part of the gut) have been reported.
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. 
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.
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. 
The main measure of effectiveness was blood levels of the stress hormone cortisol 30 minutes after surgery.
Metacam solution injectable a été étudiée chez 76 chattes subissant une ovariohystérectomie. 
Metacam injection was studied in 76 cats undergoing ovariohysterectomy.
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. 
46 cats received Metacam oral suspension for 28 days whilst 48 cats received placebo oral suspension.
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. 
Metacam injection was compared with vedaprofen (another NSAID) for pain relief associated with equine colic in 269 horses.
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. 
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.
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. 
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.
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. 
A study in 150 piglets was carried out to compare the effects of Metacam injection with placebo when given before castration.
traités par Metacam ont présenté une amélioration significative de leurs signes de diarrhée. 
Calves treated with Metacam showed a significant improvement in their signs of diarrhoea compared with the control group.
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. 
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.
ont reçu soit Metacam solution injectable, soit une injection de placebo. 
Animals received either Metacam injection or a placebo injection.
Chevaux 
Horses
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. 
The effectiveness of Metacam injection, in combination with antibiotic therapy, was studied in cattle with acute respiratory infection.
Une autre étude a été menée sur 501 veaux 
Another study in cattle involved 501 calves with diarrhoea.
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 
Metacam 5 mg/ml solution for injection was comparable to carprofen in reducing post-operative pain in cats following ovariohysterectomy.
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. 
Metacam oral suspension was studied for treatment of musculoskeletal disorders associated with lameness in two studies and compared to treatment with vedaprofen.
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). 
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).
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. 
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.
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. 
In addition slight urticaria (itchy rash) and diarrhoea can occur which are both typical side effects of NSAIDs and which resolve by themselves.
Chez les cochons d'Inde, Metacam est utilisé pour réduire la douleur postopératoire suivant une chirurgie des tissus mous, telle que la castration. 
In guinea pigs, Metacam is used to reduce post-operative pain after soft tissue surgery such as castration.
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. 
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).
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). 
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).
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. 
Metacam injection in combination with antibiotic therapy was investigated in a study involving 240 cattle with acute mastitis.
Cochons d'Inde 
Guinea pigs
Il peut être utilisé pour le traitement de la diarrhée en association avec une thérapie orale de réhydratation (médicaments administrés par voie orale pour restaurer les taux d'eau dans le corps), afin de réduire les signes cliniques de la maladie chez les veaux 
It can be used in diarrhoea in combination with oral re-hydration therapy (medicines given by mouth to restore water levels in the body) to reduce clinical signs of the disease in calves of over one week of age and young, non-lactating cattle.