FrancophonIA/ELRC3.0 huggingface dataset:
English: BAYTRILâ ORALE 0,5% sol
Bulgarian: BAYTRILâ ORALE 0,5%
English: Danofloxacin 180 mg/ml
Bulgarian: Данофлоксацин 180 mg/ml
English: Roxacin 10% oral solution, enrofloksacyna 100mg/ml, oral solution for chicken
Bulgarian: Roxacin 10% oral solution, enrofloksacyna 100mg/ml, oral
English: Veterinary medicinal products containing all the correct prudent use warnings in section 4 o f the SPC, exactly as the CVMP recommendation and Veterinary medicinal products containing all the prudent use warnings in section 4 of the SPC, which are however not exactly the text recommended by the CVMP, but conveys the same key messages Veterinary medicinal products that contain prudent use warnings in section 4 of the SPC but which do not adequately reflect the CVMP recommendations Veterinary medicinal products that do not contain the prudent use warnings in of section 4 of the SPC Veterinary medicinal products for which no information was submitted by the Applicants/Marketing Authorisation Holders or competent national authorities and for which no assessment of the existing SPC warnings was therefore possible Total The (fluoro)quinolone SPC warnings were satisfactory for 318 products, and therefore no further action needs to be taken for these products.
Bulgarian: Ветеринарномедицински продукти, съдържащи всички подходящи предупреждения за разумна употреба в точка 4 на КХП, копиращи точно препоръката на CVMP, и ветеринарномедицински продукти, съдържащи всички предупреждения за разумна употреба в точка 4 на КХП, които обаче не са записани по начина, препоръчан от CVMP, но предават същите основни съобщения
English: Germany Medistar Arzneimittel-Vertrieb GmbH
Bulgarian: Medistar ArzneimittelVertrieb GmbH Schäferkampstr.
English: MARBOCYL 2% inj
Bulgarian: MARBOCYL 2%
English: Cattle Pigs Poultry
Bulgarian: Говеда Прасета Кокошки
English: Poultry Pigs Fish
Bulgarian: Прасета Пилета Пуйки Риба
English: MARBOCYL 10% inj
Bulgarian: MARBOCYL 10%
English: ENTERFLUME 50% Flumequine
Bulgarian: ENTERFLUME 50 % Флумекин
English: Enroxil 10% oral , enrofloksacyna 100mg/ml solution for use in drinking water for chicken
Bulgarian: , enrofloksacyna 100mg/ml solution for use in drinking water for chicken
English: Calves Piglets Broilers
Bulgarian: Телета Прасенца Бройлери
English: Cattle Ovine Pigs Dogs
Bulgarian: Говеда Овце Кози Прасета Кучета
English: Enrofloxacin 5 g/100 g
Bulgarian: Енрофлоксацин 5 g/100 g
English: VETAFLUMINA 50% Flumequine
Bulgarian: VETAFLUMINA 50% Флумекин
English: Flumequine 50% WSP Flumequine
Bulgarian: Flumequine 50% WSP Флумекин
English: Poultry Pigs Sheep Cattle Fish
Bulgarian: Пилета Риба Прасета Телета Овце Кози
English: PO BOX 285
Bulgarian: Jordan Na`ur 11710 PO BOX 285
English: Enrofloxacin 200 g/1000 ml
Bulgarian: Eнрофлоксацин 200 g/1000 ml
English: Lavet Gyógyszergyártó Kft. Ottó u. 14
Bulgarian: Lavet Gyógyszergyártó Kft.
English: Romania Pharmateka BT Szíjgyártó str. 10
Bulgarian: Pharmateka BT Szíjgyártó str. 10 1048 Budapest УНГАРИЯ
English: Ursofloxacin 5% Enrofloxacin 50 mg/ml
Bulgarian: Ursofloxacin 5% Eнрофлоксацин 50 mg/ml
English: Enrovet Inyectable 100 Enrofloxacin 100 mg/ml
Bulgarian: Enrovet Inyectable 100 Енрофлоксацин 100 mg/ml
English: Cattle (suckling calves)
Bulgarian: Говеда (телета)
English: Sanofi Santè Nutrition Animale , La Ballestière - Bp 126 , 33051, Francia
Bulgarian: , La Ballestière - Bp 126
English: 11.5 g/100 g Oral powder
Bulgarian: g/100 g Перорален прах
English: 10% Enrofloxacin 100 mg/g
Bulgarian: 10% Енрофлоксацин 100 mg/g
English: Enrofloxarom Forte Enrofloxacin 50 mg/tablet
Bulgarian: Enrofloxarom Forte Енрофлоксацин 50 mg/таблетка Таблетки
English: Cattle Buffalos Calves Foals Lambs Kids Pigs Piglets Rabbits Fowl
Bulgarian: Говеда Биволи Телета Жребчета Агнета Ярета Прасета Прасенца Зайци Кокошки
English: Pigs Dogs Cats
Bulgarian: Прасета Кучета Котки
English: Active substance(s)
Bulgarian: Активна/и субстанция/и
English: Enrokarizoo 10% Enrofloxacin 10 g/100 ml
Bulgarian: Enrokarizoo 10% Енрофлоксацин 10 g/100 ml
English: Cattle Pigs Dogs Cats
Bulgarian: Говеда Прасета Кучета Котки
English: Poultry (broilers and turkeys)
Bulgarian: Пилета (бройлери)
English: Germany Krka, d. d., Novo mesto Šmarješka cesta 6
Bulgarian: Португалия Krka, d. d., Novo mesto Šmarješka cesta 6
English: FLUMAX 50% Flumequine
Bulgarian: FLUMAX 50% Флумекин
English: Romania Bayer HealthCare AG Animal Health Division 51368 Leverkusen
Bulgarian: Health Division 51368 Leverkusen
English: Roxacin Inyectable Enrofloxacin 100 mg/ml
Bulgarian: Roxacin Inyectable Енрофлоксацин 100 mg/ml
English: Enrofloxacin 100 mg/g
Bulgarian: Enrofloxacin 100 mg/ml
English: Intraruminal device Cattle
Bulgarian: Перорален разтвор Говеда
English: • for 132 the products identified by the Member States no or insufficient information was made available to the CVMP by the Applicants/Marketing Authorisation Holders or national authorities and therefore no conclusion on the availability or assessment the adequacy of precautionary phrases in the Summary of the Product Characteristics was possible; the Committee recommends the variation of the terms of the marketing authorisations of products containing quinolones including fluoroquinolones intended for food producing species as referred in Annex I in order to amend the Summary of the Product Characteristics and Package Leaflets in those cases where there are not in line with the CVMP Reflection Paper (EMEA/CVMP/416168/2006).
Bulgarian: Кратката характеристика на продукта и листовката за употреба в онези случаи, които не са в съответствие с дискусионния документ на Комитета (EMEA/CVMP/416168/2006).
English: Recommendations for prudent use “Official and local antimicrobial policies should be taken into account when the product is used.” “Whenever possible, quinolones should only be used based on susceptibility testing.” “Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the quinolones and may decrease the effectiveness of treatment with other (fluoro)quinolones due to the potential for cross resistance.”
Bulgarian: „По възможност хинолоните трябва да се прилагат само въз основа на изследване за чувствителност.” „Употреба на продукта, която се отклонява от указанията в КХП, може да повиши разпространението на бактерии, резистентни на хинолони, и да понижи ефективността от лечението с други (флуоро)хинолони, поради възможност за кръстосана резистентност.”
English: Poulrty
Bulgarian: Пъстърва
English: Marbocyl 2 % Marbofloxacin 2%
Bulgarian: MARBOCYL 2% Марбофлоксаци н
English: Wirtz Farma B.V.
Bulgarian: Kepro B.V.
English: Danofloxacin 25 mg/ml
Bulgarian: Данофлоксацин 25 mg/ml
English: Intravenous, subcutaneous
Bulgarian: Интравенозно, подкожно
English: Anka-floxacin 10% Enrofloxacin 100 mg/ml
Bulgarian: Anka-floxacin 10% Енрофлоксацин 100 mg/ml
English: Flumisol 10 % Flumequine
Bulgarian: Flumisol 10 % Флумекин
English: Marbocyl 10% Marbofloxacin 10%
Bulgarian: Marbocyl 10% Марбофлоксаци н
English: Baytril 5 % injection Enrofloxacin 50 mg/ml
Bulgarian: Baytril 5 % injection Eнрофлоксацин 50 mg/ml
English: Lithuania Dopharma Research BV Zalmweg 24
Bulgarian: Нидерландия Dopharma Research BV Zalmweg 24
English: Marbocyl 10% Marbofloxacin per ml: marbofloxacin
Bulgarian: Marbocyl 10% Марбофлоксаци н за ml: марбофлоксаци н 100 mg
English: Cattle (calves) Pigs
Bulgarian: Говеда (телета) Прасета Кучета
English: Baytril 10 % injection Enrofloxacin 100 mg/ml
Bulgarian: Baytril 10 % injection Eнрофлоксацин 100 mg/ml
English: Fenoflox 5 % Enrofloxacin 100 mg/ml
Bulgarian: Fenoflox 5 % Eнрофлоксацин 100 mg/ml
English: Flumesol 10% Flumequine
Bulgarian: Flumesol 10% Флумекин
English: Enrofloxacin 0.5%
Bulgarian: Енрофлоксацин 0.5%
English: Enrofloxacin 2.5%
Bulgarian: Енрофлоксацин 2.5%
English: Pigs Broilers Turkeys
Bulgarian: Прасета Бройлери Пуйки
English: Coophavet S.A.S Saint Herblion, B.P.
Bulgarian: Coophavet S.A.S Saint Herblion, B.P. 7 44153 Ancenis Cedex ФРАНЦИЯ
English: Oxolinic acid 5 g/100 g
Bulgarian: Eнрофлоксацин 5 g/100 g
English: Poultry (chickens and turkeys)
Bulgarian: Домашни птици (пилета и пуйки)
English: Poultry (excluding laying)
Bulgarian: Перорален разтвор Пилета (с изключение на кокошки носачки)
English: Rodents (rabbit, guinea pigs, mice, hamsters) Hunting birds Exotic birds Dogs
Bulgarian: Гризачи (зайци, морски свинчета, мишки, хамстери)
English: Intravenous, intramuscular, subcutaneous
Bulgarian: Интравенозно, интрамускулно, подкожно
English: Str. Stadionului nr. 1
Bulgarian: - piso 1 escritorio 3
English: Enrofloxacin 100 g/l
Bulgarian: Енрофлоксацин 100 g/l
English: Enroxil 5 % injection Enrofloxacin 50 mg/ml
Bulgarian: Enroxil 5% injection Eнрофлоксацин 50 mg/ml
English: Enroxil 5% injection Enrofloxacin 50 mg/ml
Bulgarian: Enroxil 5 % injection Eнрофлоксацин 50 mg/ml
English: Oral powder
Bulgarian: Перорален прах
English: Enrofloxacin 100 g/1000 ml
Bulgarian: Енрофлоксацин 100 g/1000 ml
English: Enrocin 5% inj., enrofloksacyna 50mg/ml solution for injection for cattle and pig
Bulgarian: inj., enrofloksacyna 50mg/ml solution for injection for cattle and pig
English: Enrofloxacin 2.5 g/100 ml
Bulgarian: Eнрофлоксацин 2.5 g/100 ml
English: C-Enrox 10% Enrofloxacin 100 mg/ml
Bulgarian: C-Enrox 10% Енрофлоксацин 100 mg/ml
English: • Fluoroquinolone products “Official and local antimicrobial policies should be taken into account when the product is used.” “Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.” “Whenever possible, fluoroquinolones should only be used based on susceptibility testing.” “Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.”
Bulgarian: „По възможност флуорохинолоните трябва да се прилагат само въз основа на изследване за чувствителност.” „Употреба на продукта, която се отклонява от указанията в Кратката характеристика на продукта, може да повиши разпространението на бактерии, резистентни на флуорохинолони, и да намали ефективността от лечението с други хинолони, поради възможност за кръстосана резистентност.”
English: Enrofloksacyna 10% liquid, enrofloksacyna 100mg/ml oral solution for chicken
Bulgarian: Enrofloksacyna 10% liquid, enrofloksacyna 100mg/ml oral
English: Belgium Vétoquinol N.V. Kontichsesteenweg 42
Bulgarian: Нидерландия Vétoquinol B.V. Bruistensingel 310
English: Cattle Pigs Poultry Rabbits
Bulgarian: Прасета Домашни птици Зайци
English: Rabbits Fur animals
Bulgarian: Пъстървови риби
English: Oxolinic acid 100 mg
Bulgarian: Eнрофлоксацин 100 mg
English: Intramuscular, subcutaneous
Bulgarian: Интрамускулно, подкожно
English: Cattle Sheep Goats Pigs
Bulgarian: Говеда Прасета Овце Кози
English: Flumequine 10% Flumequine
Bulgarian: Flumequine 10% Флумекин
English: Pig
Bulgarian: Прасенца
English: Subcutaneous, intravenous
Bulgarian: Подкожно, интравенозно
English: Chickens Cattle
Bulgarian: Пилета Говеда
English: Ruminating calves
Bulgarian: Стомашно-чревен разтвор
English: Oxolinic acid 5 g/100 ml
Bulgarian: Eнрофлоксацин 5 g/100 ml
English: Cattle Goats Horses Sheep Pigs Poultry
Bulgarian: Говеда Кози Овце Прасета
English: Syvaquinol 10% Enrofloxacin 100 mg/ml
Bulgarian: Syvaquinol 10% Енрофлоксацин 100 mg/ml
English: Pigs Lambs Cattle Hens Turkeys
Bulgarian: Прасета Агнета Говеда Кокошки Пуйки
English: Baytril 5% inj enrofloksacyna 50 mg/ml solution for injection for cattle and pig
Bulgarian: inj enrofloksacyna 50 mg/ml solution for injection for cattle and pig
English: Flumequine 50% Flumequine
Bulgarian: Flumequine 50% Флумекин
English: Vetoflok 10% Enrofloxacin 100 mg/ml
Bulgarian: Vetoflok 10% Енрофлоксацин 100 mg/ml
English: Enroxil 10% solution Enrofloxacin 100 mg/ml
Bulgarian: Enroxil 10% solution Eнрофлоксацин 100 mg/ml
English: Schäferkampstr.
Bulgarian: Hungária Kft.
English: Calves Lambs Goatlings Rabbits Fur animals
Bulgarian: Перорален разтвор Бройлери Зайци
English: Flumisol 100mg/ml oral solution for chicken, tureky, pig, cattle and sheep
Bulgarian: solution for chicken, tureky, pig, cattle and sheep
English: Enrofloxacin 25 mg/tablet
Bulgarian: Енрофлоксацин 25 mg/таблетка Таблетки
English: Belgium Bayer N.V. Louizalaan 143
Bulgarian: Нидерландия Bayer B.V. Animal
English: Enrofloxacin 5 g/100 ml
Bulgarian: Енрофлоксацин 5 g/100 ml
English: Poultry (chicken and turkeys) Pigeons
Bulgarian: solution for chicken and pigeons
English: Calves Poultry
Bulgarian: Пилета Бройлери
English: Flumechina 50% Flumequine
Bulgarian: Flumechina 50%
English: Calves Lambs Poultry
Bulgarian: Перорален разтвор Бройлери пилета
English: Belgium Codifar N.V. Lt. Caluwaertstraat 1
Bulgarian: Нидерландия Wirtz Farma B.V. Leijsendwarsstraat 26
English: Enrovet 10 % solution Enrofloxacin 100 mg/ml
Bulgarian: Enrovet 10 % solution Eнрофлоксацин 100 mg/ml
English: Enrofloxacina 10% Enrofloxacin 100 mg/ml
Bulgarian: Enrofloxacina 10% Енрофлоксацин 100 mg/ml
English: Quinocol oral solution Enrofloxacin Colistin sulphate
Bulgarian: Quinocol oral solution Енрофлоксацин Колистин сулфат
English: Quinocol Oral Solution Enrofloxacin Colistin sulphate
Bulgarian: Quinocol Oral Solution Енрофлоксацин Колистин сулфат
English: Cattle Sheep
Bulgarian: Говеда Овце Кози
English: Enrofloxacin 500 mg/g
Bulgarian: Енрофлоксацин 500 mg/g
English: Intravenous, intramuscular
Bulgarian: Интрамускулно, интравенозно
English: Fenoflox 10 % Enrofloxacin 100 mg/ml
Bulgarian: Fenoflox 10% Енрофлоксацин 100 mg/ml
English: Enrofloxacin 250 mg
Bulgarian: Енрофлоксацин 250 mg
English: Enrobioflox 10% Enrofloxacin 100 mg/ml
Bulgarian: Enrobioflox 10% Енрофлоксацин 100 mg/ml
English: Intramuscular, subcutaneous, intravenous
Bulgarian: Интрамускулно, подкожно, интравенозно
English: Romania Golashpharma Ltd. 33, Pobeda Str.
Bulgarian: 33, Pobeda Str.
English: Cattle Lambs Yeanlings Poultry Birds Rabbits
Bulgarian: Перорален разтвор Говеда Птици
English: Ursofloxacin 10% Enrofloxacin 100 mg/ml
Bulgarian: Ursofloxacin 10% Eнрофлоксацин 100 mg/ml
English: Enflocyna SOL 50mg/ml oral solution for cattle, pig, dog, chicken, tureky and pigeons
Bulgarian: solution for cattle, pig, dog, chicken, tureky and pigeons
English: Enroxil 10 % injection Enrofloxacin 100 mg/ml
Bulgarian: Enroxil 10% injection Eнрофлоксацин 100 mg/ml
English: Enroxil 10% injection Enrofloxacin 100 mg/ml
Bulgarian: Enroxil 10 % injection Eнрофлоксацин 100 mg/ml
English: Fattening Chickens Fattening Turkeys
Bulgarian: Перорален разтвор Пилета Пуйки
English: Enrofloxacin 10 g/100 ml
Bulgarian: Енрофлоксацин 10 g/100 ml
English: Oltenita
Bulgarian: АгнетаЯрета
English: Oxolinic acid 50 mg
Bulgarian: Eнрофлоксацин 50 mg
English: 10g/100g
Bulgarian: 10г/100г
English: Poultry Cattle Fur animals
Bulgarian: Домашни пилета Говеда
English: Enrofloxarom 10% Enrofloxacin 100 mg/ml
Bulgarian: Enrofloxarom 10% Енрофлоксацин 100 mg/ml
English: BAYTRIL 5% Sol. inj.
Bulgarian: BAYTRIL 5% Sol.
English: Enroxil 10% , enrofloksacyna 100mg/ml solution for injection for cattle and pig
Bulgarian: , enrofloksacyna 100mg/ml solution for injection for cattle and pig
English: Subcutaneous, intramuscular, intravenosous
Bulgarian: Подкожно, интрамускулно, интравенозно
English: Oxolinic acid 50 mg/ml
Bulgarian: Eнрофлоксацин 50 mg/ml
English: Cattle Chickens Turkeys
Bulgarian: Говеда Пилета Пуйки
English: Rabbits Dogs Cats Chickens
Bulgarian: Прасета Зайци Кучета Котки
English: Enrofloxacin 10%
Bulgarian: Enrofloksacyna 10%
English: Pigs Cattle Poultry Fish
Bulgarian: Прасета Домашни птици Риба
English: 20050 Sulbiate Sup.
Bulgarian: 20050 Sulbiate Sup. (MI) ИТАЛИЯ
English: Chickens Dogs Cats
Bulgarian: Жребчета Кучета Котки
English: Enrofloxacin 150 mg
Bulgarian: Енрофлоксацин 150 mg
English: Oxolinic acid 0.08 g
Bulgarian: 0,08 g
English: Cattle Sheep Goats Sows
Bulgarian: Маслена суспензия Говеда Овце
English: Flumiquil 50 % Flumequine
Bulgarian: Flumiquil 50 % Флумекин
English: Enrofloxacin 10 % Enrofloxacin 100 mg/ml
Bulgarian: Enrofloxacin 10 % Eнрофлоксацин 100 mg/ml
English: Enrovet 10% Enrofloxacin 100 mg/ml
Bulgarian: Enrovet 10% Енрофлоксацин 100 mg/ml
English: Oxolinic acid 100 mg/g
Bulgarian: Енрофлоксацин 100 mg/g
English: Cattle Lambs Pigs
Bulgarian: Говеда Прасенца
English: Amoxicillin trihydrate Flumequine
Bulgarian: Амоксицилин трихидрат Флумекин
English: Enrofloxacin 15 mg/tablet
Bulgarian: Енрофлоксацин 15 mg/таблетка Таблетки
English: Enrofloxacin 5 mg/tablet
Bulgarian: Енрофлоксацин 5 mg/таблетка Таблетки
English: Enrofloxacin Colistin sulphate
Bulgarian: Енрофлоксацин Колистин сулфат
English: Cattle Goats Rabbits Sheep Fish Pigs Poultry
Bulgarian: Говеда Кози Овце Прасета Зайци
English: Cattle (neonatal calves)
Bulgarian: Говеда (новородени телета)
English: Denmark Krka, d. d., Novo mesto Šmarješka cesta 6
Bulgarian: Нидерландия Krka, d. d., Novo mesto Šmarješka cesta 6
English: Flumequine Amoxicillin trihydrate
Bulgarian: Флуорохинолонови продукти
English: Enrofloxacin 50 mg/g
Bulgarian: Енрофлоксацин 50 mg/g
English: Enrodem 10% Enrofloxacin 100 mg/ml
Bulgarian: Enrodem 10% Енрофлоксацин 100 mg/ml
English: Poultry Pigeons Cats Dogs Cattle Pigs
Bulgarian: Говеда Овце Кози Прасета Кучета Котки
English: Broilers Rabbits
Bulgarian: Зайци Коне
English: Ref. EMEA/690893/2008
Bulgarian: Номер на документа EMEA/86048/2009
English: London, 22 January 2009 Doc.
Bulgarian: Лондон, 22 януари
English: The Committee also had concerns over what happens to the medicine in the body, how it should be given and how safe it is.
Bulgarian: Комитетът има също така опасения относно това какво става с лекарството в организма, как би трябвало то да се прилага и доколко е безопасно.
English: People who have this mutation are more likely to develop cancer.
Bulgarian: За хората, които имат тази мутация, е много по-вероятно да развият рак.
English: International non-proprietary name (INN): contusugene ladenovec
Bulgarian: Международно непатентовано име (INN): контусуген ладеновек
English: Advexin was designated as an orphan medicinal product on 23 October 2006.
Bulgarian: Advexin е определен за лекарство сирак на 23 октомври 2006 г.
English: Li-Fraumeni cancer can occur in many areas of the body but usually affects the breast, brain, bone or soft tissue (tissue that connects, surrounds and supports other structures in the body).
Bulgarian: Ракът на Ли-Фраумени може да се появи в много области на тялото, но обикновено засяга гърдите, мозъка, костите или меките тъкани (тъканите, които свързват, заобикалят и поддържат другите структури в тялото).
English: The patient received 12 Advexin injections into some of the tumours over a five-month period.
Bulgarian: Пациентът е получил 12 инжекции Advexin в някои от туморите за период от 5 месеца.
English: Questions and answers on the withdrawal of the marketing application for Advexin
Bulgarian: Въпроси и отговори относно оттеглянето на заявлението за разрешение за употреба за Advexin
English: The company also presented the results of a number of small studies looking at the effects of a range of doses of Advexin on different types of cancer.
Bulgarian: Компанията представя също така резултатите от редица малки проучвания, разглеждащи ефектите на различни дози Advexin върху различни видове рак.
English: In addition, the company had not supplied enough evidence to demonstrate that Advexin could be made in a reliable manner, or that it would not be harmful to the environment or to people in close contact with the patient.
Bulgarian: В допълнение компанията не е представила достатъчно доказателства в подкрепа на това, че Advexin би могъл да се произвежда по надежден начин или че не би бил вреден за околната среда или за хората в близък контакт с пациента.
English: What is Advexin?
Bulgarian: Какво представлява Advexin?
English: On 17 December 2008, Gendux Molecular Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Advexin for the treatment of Li-Fraumeni cancer.
Bulgarian: На 17 декември 2008 г. Gendux Molecular Limited уведомява официално Комитета по лекарствените продукти за хуманна употреба (CHMP), че желае да оттегли заявлението си за разрешение за употреба за Advexin за лечение на рак на Ли-Фраумени.
English: The effectiveness of the medicine was assessed by using scans to look at how the tumours responded to treatment.
Bulgarian: Ефективността на лекарството е оценена, като е използвано сканиране за разглеждане на реакцията на туморите към лечението.
English: Advexin was expected to cure or slow down the disease by restoring the normal protective function of the cells.
Bulgarian: Очаквало се е Advexin да лекува или забавя заболяването чрез възстановяване на нормалната защитна функция на клетките.
English: This is a type of virus that has been altered genetically so that it can carry a gene into the cells of the body.
Bulgarian: Това е вид вирус, който е променен генетично, така че да може да внесе определен ген в клетките на тялото.
English: The virus in Advexin is an ‘adenovirus' that has been engineered so that it cannot make copies of itself and therefore does not cause infections in humans.
Bulgarian: Вирусът в Advexin е „аденовирус“, който е създаден така, че да не може да се възпроизвежда, и следователно не може да причини инфекции при хората.
English: Advexin was expected to be used to treat Li-Fraumeni cancer in patients from the age of 18 years.
Bulgarian: Очаквало се е Advexin да се използва за лечение на рак на Ли-Фраумени при пациенти на възраст 18 години или повече.
English: The active substance in Advexin, contusugene ladenovec, is a ‘viral vector'.
Bulgarian: Активното вещество в Advexin, контусуген ладеновек, е „вирусен вектор“.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Bulgarian: След като компанията представи отговори на въпросите, CHMP ги преглежда и преди да формулира становище, може да постави допълнителни въпроси на ден 180.
English: The company presented information from a study on one patient with Li-Fraumeni cancer in the lower abdomen, the bones and the brain.
Bulgarian: Компанията е представила данни от проучване при един пациент с рак на Ли-Фраумени в долната част на корема, костите и мозъка.
English: What was Advexin expected to be used for?
Bulgarian: За какво се е очаквало да се използва Advexin?
English: What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Advexin?
Bulgarian: Какви са последствията от оттеглянето на заявлението за пациентите, участващи в клинични изпитвания или в програми за палиативна употреба Advexin?
English: How is Advexin expected to work?
Bulgarian: Как се очаква да действа Advexin?
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Advexin could not have been approved for the treatment of Li-Fraumeni cancer.
Bulgarian: Въз основа на прегледа на информацията и отговорите на компанията по списъка с въпроси на CHMP, към момента на оттеглянето CHMP има известни опасения и изразява предварителното становище, че не е било възможно Advexin да бъде одобрен за лечение на рак на Ли-Фраумени.
English: Advexin was expected to be injected directly into the tumours, thus allowing the cancer cells to produce normal p53 protein again.
Bulgarian: Очаквало се е Advexin да се инжектира директно във туморите и така да позволява на раковите клетки отново да произвеждат нормалния протеин р53.
English: The company did not inform the CHMP whether there were any consequences of the withdrawal for patients in clinical trials or compassionate use programmes with Advexin.
Bulgarian: Компанията не е уведомила CHMP дали има последствия от оттеглянето на заявлението за пациентите, участващи в клинични изпитвания или в програми за палиативна употреба с Advexin.