natgillin/translations-raw huggingface dataset:
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.
326 bovins ont reçu Metacam solution injectable, en association avec un traitement par antibiotiques, tandis que 326 autres bovins ont reçu une injection de placebo (fictive) et un traitement par antibiotiques. Chez les bovins, par rapport aux antibiotiques seuls, Metacam solution injectable a considérablement atténué les signes cliniques de l'infection respiratoire et a fait baisser la fièvre.
326 cattle received Metacam given as an injection together with antibiotic therapy whilst 326 cattle received a placebo (dummy) injection and antibiotic therapy.
Chiens
Dogs
Porcins
Pigs
L'efficacité de Metacam solution injectable a été étudiée chez 209 porcins présentant des troubles locomoteurs non infectieux. Les porcins ont reçu soit Metacam, soit une injection de placebo.
The effectiveness of Metacam injection was studied in 209 pigs with non-infectious locomotor disorders.
Plusieurs études ont été menées sur le Metacam oral et injectable chez des chiens présentant des troubles locomoteurs aigus et chroniques. Les études menées sur les troubles locomoteurs chroniques ont démontré l'efficacité de Metacam dans ce cadre.
A number of studies were conducted in dogs with acute and chronic locomotor disorders with both oral and injectable Metacam.
sur le comportement de l'animal, sa consommation d'aliments, sa température corporelle, sa fréquence respiratoire, sa fréquence cardiaque et son état général.
The main measure of effectiveness was based on clinical signs of diarrhoea and the animal's behaviour, feed intake, body temperature, respiratory rate, heart rate and general condition.
temporaire a été observé au site d'injection après l'administration sous-cutanée chez la plupart des bovins étudiés dans des conditions de laboratoire.
In cattle and pigs, Metacam is well tolerated; only a slight temporary swelling at the injection site following subcutaneous administration was observed in most cattle studied in laboratory conditions.
Metacam solution injectable a fait l'objet d'une étude incluant 60 veaux, parmi lesquels un groupe a reçu Metacam associé à un anesthésique local, tandis que l'autre groupe a reçu une injection de placebo associée à un anesthésique local avant l'ablation des cornes. L'étude a montré que Metacam s'avère efficace pour réduire la douleur associée à l'ablation des cornes.
Metacam injection was studied in 60 calves with one group receiving Metacam and local anaesthetic and one group receiving a placebo injection and local anaesthetic prior to dehorning.
Comment Metacam agit-il?
How does Metacam work?
Par rapport au groupe témoin, Metacam a été efficace du jour 0 au jour 14 pour améliorer la mobilité et réduire la douleur.
Metacam was effective in improving mobility and reducing pain from day 0-14 compared to the control group.
Chats
Cats
Des réactions anaphylactoïdes et une élévation des enzymes hépatiques ont été signalées dans de très rares cas. Ces effets indésirables disparaissent après l'arrêt du traitement.
In very rare cases anaphylactoid reactions and elevated liver enzymes have been reported.
Chez les porcins, Metacam est utilisé pour réduire la claudication et l'inflammation dans les troubles locomoteurs non infectieux (maladies qui affectent la mobilité), pour soulager la douleur postopératoire associée à une petite chirurgie des tissus mous, telle que la castration, et en tant que thérapie de soutien assortie d'antibiotiques pour le traitement de maladies qui font
In pigs, Metacam is used in non-infectious locomotor disorders (diseases that affect the ability to move) to reduce lameness and inflammation, relieve post-operative pain associated with minor soft tissue surgery such as castration, and for supportive therapy together with antibiotics in the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome, a bacterial infection of the udder and/or the womb).
s'est révélée comparable à celle du kétoprofène pour atténuer la claudication et la douleur.
Metacam oral suspension was comparable to ketoprofen in improving lameness and pain.
Une étude a été réalisée sur des chats atteints de troubles musculo-squelettiques aigus. Metacam suspension orale a été administrée pendant 5 jours et comparé à un traitement par kétoprofène (un autre AINS).
Metacam oral suspension was given for 5 days and compared with ketoprofen (another NSAID).
Chez les chiens, une diarrhée hémorragique (diarrhée sanglante), une hématémèse (vomissement de sang) ou une ulcération gastro-intestinale (ulcère dans l'intestin) ont été signalées dans de très rares cas. Ces effets indésirables apparaissent habituellement au cours de la première semaine de traitement et sont généralement transitoires (temporaires).
In very rare cases, in dogs, haemorrhagic diarrhoea (bloody diarrhoea), haematemesis (vomiting blood) or gastrointestinal ulceration (ulcer in the gut) have been reported.
âgés de plus d'une semaine et chez les jeunes bovins non allaitants. Il peut être utilisé pour soulager la douleur postopératoire consécutive à l'ablation des cornes chez les veaux et comme thérapie de soutien pour le traitement de la mammite aiguë (inflammation des mamelles), en combinaison avec des antibiotiques.
It can be used to relieve post-operative pain following dehorning in calves and as supportive therapy in the treatment of acute mastitis (inflammation of the udder), in combination with antibiotics.
Metacam contient du méloxicam, un médicament de la classe des anti-inflammatoires non stéroïdiens (AINS). Le méloxicam agit en bloquant une enzyme appelée «cyclooxygénase», qui joue un rôle dans la production des prostaglandines. Étant donné que les prostaglandines sont des substances qui déclenchent l'inflammation, la douleur, l'exsudation (liquide qui suinte des vaisseaux sanguins lors d'une inflammation) et la fièvre, ces symptômes sont atténués par le méloxicam.
As prostaglandins are substances that trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during an inflammation) and fever, meloxicam reduces these signs of disease.
Chez les chats, Metacam est utilisé pour réduire la douleur postopératoire et l'inflammation suivant une ovariohystérectomie (ablation des ovaires), une chirurgie orthopédique ou une petite chirurgie des tissus mous. Par ailleurs, il est utilisé pour soulager la douleur et l'inflammation dans les troubles musculo-squelettiques aigus ou chroniques.
In cats, Metacam is used to reduce post-operative pain and inflammation after ovariohysterectomy (spay operation), orthopaedic and minor soft tissue surgery.
ayant reçu Metacam, tandis que la deuxième étude a montré que Metacam était comparable au védaprofène.
Metacam improved lameness in horses at day 14 and at the final follow-up examination 2-4 days later than the vedaprofen treated group whilst the second study showed Metacam to be comparable to vedaprofen.
Metacam est disponible sous la forme d'une suspension orale (administrée par la bouche), d'une solution injectable et de comprimés à croquer. Les injections peuvent être faites dans une veine, dans des muscles ou sous la peau. La formulation et la dose à utiliser dépendent de l'espèce animale, de son poids corporel et du problème médical traité.
Metacam is available as an oral (taken by mouth) suspension, a solution for injection and chewable tablets.
Chez les chiens, Metacam est utilisé pour réduire la douleur postopératoire et l'inflammation suivant une chirurgie orthopédique (par exemple, opération pour réparer une fracture) ou une chirurgie des tissus mous. Par ailleurs, il est utilisé pour soulager l'inflammation et la douleur dans les troubles musculo-squelettiques aigus ou chroniques chez les chiens.
In dogs, Metacam is used to reduce post-operative pain and inflammation following orthopaedic (e.g. fracture operation) and soft tissue surgery.
Une thérapie orale de réhydratation ainsi que des antibiotiques ont été administrés à tous les veaux. Le principal critère d'évaluation de l'efficacité était fondé sur les signes cliniques de diarrhée et
All calves were given oral rehydration therapy and antibiotics.
ont reçu une injection unique de Metacam ou de flunixine (un autre AINS), pendant 5 jours au maximum. Le principal critère d'évaluation de l'efficacité était fondé sur l'état général de l'animal, l'apparence du lait et des signes d'inflammation des mamelles. Les résultats de Metacam se sont révélés comparables à ceux du produit témoin dans le cadre d'un traitement d'appoint de la mammite aiguë chez les bovins.
The main measure of effectiveness was based on their general condition, milk appearance and signs of udder inflammation.
Безопасността и ефикасността при деца на възраст под 18 години не са установени.
Safety and efficacy in children aged under 18 years have not been established.
Вашият лекар ще ги обсъди с Вас и ще Ви обясни възможните рискове и ползи от лечението.
Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.
18 месеца
18 months.
След първоначалното разпечатване: от микробиологична гледна точка продуктът трябва да се използва незабавно.
After first opening: from a microbiological point of view, the product should be used immediately.
Вашият лекар редовно ще проверява за наличие на тези симптоми.
Your doctor will check for these symptoms regularly.
Информирайте медицинския екип, който ви наблюдава през това време, ако страдате от:
Tell the medical staff monitoring you during this time, if you suffer from:
− Запазете тази листовка.
− Keep this leaflet.
Възрастни и хора в старческа възраст
Adults and the elderly
Дата на последно разрешение: 11 юли 2011
Date of first authorisation: 11 July 2001 Date of latest renewal: 11 July 2011
− Ако имате някакви допълнителни въпроси, попитайте Вашия лекар.
− If you have further questions, ask your doctor.
Прочетете внимателно цялата листовка, преди да Ви бъде приложено това лекарство, тъй като тя съдържа важна за Вас информация.
Read all of this leaflet carefully before you receive this medicine because it contains important information for you.
Препоръчваната доза ще Ви бъде приложена от лекаря, както е необходимо.
The recommended dose will be given to you by the doctor or physician as necessary.
DepoCyte не се препоръчва за употреба при деца и юноши, до получаване на повече данни.
DepoCyte is not recommended for use in children and adolescents until further data become available.
Моля уведомете Вашия лекар, ако приемате или наскоро сте приемали други лекарства, включително и такива, отпускани без рецепта.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Съществуващите за момента данни са описани в точка 5.1, но не може да се дадат препоръки за дозировка.
Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Не шофирайте по време на лечението.
Do not drive during treatment.
Тъй като тези реакции са съобщавани от популация с неопределен размер, не е възможно честотата им да бъде оценена надеждно.
Because these reactions are reported from a population of uncertain size, it is not possible to reliably estimate their frequency.
При повечето пациенти подобно лечение ще бъде част от симптоматичното палиативно лечение на заболяването.
In the majority of patients such treatment will be part of symptomatic palliation of the disease.
Тези реакции са били съобщавани главно от постмаркетинговия опит с DepoCyte като спонтанни съобщения.
These reactions have been reported mainly from post-marketing experience with DepoCyte as spontaneous case reports.
За допълнителна информация относно това лекарствo, моля, свържете се с локалния представител на притежателя на разрешението за употреба:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Затова е препоръчително да се следи функционирането на хемопоетичната система.
Therefore monitoring of the haemopoietic system is advised.
НОМЕР НА РАЗРЕШЕНИЕТО ЗА УПОТРЕБА EU/1/01/187/001
EU/1/01/187/001
Вижте точка 4.
See section 4..
трябва да се определи специална зона за подготовка (за предпочитане под система с ламинарен поток).
• a designated area should be defined for preparation (preferably under a laminar flow system).
Въпреки това, въз основа на известните нежелани реакции, пациентите трябва да бъдат съветвани да не шофират или работят с машини по време на лечението.
However, on the basis of reported adverse reactions, patients should be advised against driving or using machines during treatment.
Токсичните ефекти може да бъдат свързани с еднократна доза или с кумулативни дози.
Toxic effects may be related to a single dose or to cumulative doses.
DepoCyte не трябва да се разрежда или да се смесва с никакви други лекарствени продукти, тъй като всяка промяна в концентрацията или в pH може да повлияе на стабилността на микрочастиците.
DepoCyte should not be diluted or mixed with any other medicinal products, as any change in concentration or pH may affect the stability of the microparticles.
Жени с детероден потенциал/контрацепция при мъже и жени
Women of childbearing potential/Contraception in males and females
Не са провеждани проучвания за тератогенното действие на DepoCyte върху животни и няма достатъчни и добре контролирани проучвания при бременни жени.
Teratology studies in animals have not been conducted with DepoCyte and there are no adequate and well controlled studies in pregnant women.
Не работете с машини или други инструменти по време на лечението.
Do not operate any tools or machines during treatment.
Ако се развие невротоксичност, дозата трябва да бъде редуцирана на 25 mg.
If neurotoxicity develops, the dose should be reduced to 25 mg.
Трябва да се вземат подходящи предпазни мерки за работа и приложение на цитотоксично лекарство (правилна техника на работа, използване на подходяща определена за това зона, предпазно облекло, процедури за намаляване на риска от замърсяване).
Proper precautions should be taken for the handling and administration of a cytotoxic drug (proper handling technique, use of a suitable designated area, protective clothing, procedures to address risk of contamination).
Овладяването на предозирането трябва да бъде насочено към поддържане на жизнените функции.
Management of overdose should be directed at maintaining vital functions.
Други лекарства и DepoCyte
Other medicines and DepoCyte
Над 90% от цитарабин е бил отделен до четвъртия ден и още 2,7% до 21-ия ден.
More than 90% of cytarabine was excreted by day 4 and an additional 2.7% by 21 days.
Пациентите трябва да бъдат наблюдавани от лекаря за непосредствено възникващи токсични реакции.
Patients should be observed by the physician for immediate toxic reactions.
Тъй като токсични ефекти могат да се проявят във всеки момент по време на лечението (въпреки че са най-вероятни в рамките на 5 дни от прилагането), пациентите на лечение с DepoCyte трябва да бъдат проследявани непрекъснато за развитие на невротоксичност.
Because toxic effects can occur at any time during therapy (although they are most likely within 5 days of administration), patients receiving DepoCyte therapy should be monitored continuously for the development of neurotoxicity.
5 ml
Each 5 ml
Частична парализа
• Partial paralysis
Нежелани реакции могат да се проявят след всяка инжекция, обичайно в рамките на първите пет дни.
Side effects may occur after each injection, usually within the first five days.
< PC: {номер} [код на продукта]
PC: {number} SN: {number} NN: {number}
DepoCyte не трябва да се смесва с никакви други лекарствени продукти (вж. точка 6.2).
DepoCyte must not be mixed with any other medicinal products (see section 6.2).
Механизмът на действие не е напълно изяснен, но изглежда ara-CTP действа основно посредством потискане на синтеза на ДНК.
The mechanism of action is not completely understood, but it appears that araCTP acts primarily through inhibition of DNA synthesis.
Ако не се лекува, химическият арахноидит може да бъде фатален.
If left untreated, chemical arachnoiditis may be fatal.
Постоянна или прекомерна сънливост
• Persistent or extreme sleepiness
Не са отчетени статистически значими различия във вторичните крайни точки като продължителност на отговора, преживяемост без прогресия, неврологични симптоми, статус по скалата на Karnofsky, качество на живот и цялостна преживяемост.
No statistically significant differences were noted in secondary endpoints such as duration of response, progression-free survival, neurological signs and symptoms, Karnofsky performance status, quality of life and overall survival.
DepoCyte трябва да се инжектира бавно за период от 1-5 минути.
DepoCyte should be injected slowly over a period of 1-5 minutes.
Следователно, както при всяко интратекално цитотоксично лечение, трябва да се обмисли необходимостта от оценка на ликворната циркулация преди започване на лечението.
Therefore, as with any intrathecal cytotoxic therapy, consideration should be given to the need for assessment of CSF flow before treatment is started.