Carbaglu

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

Buy It Now

Patient Information leaflet Patient Information leaflet (PIL)
19-07-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
19-07-2023
Public Assessment Report Public Assessment Report (PAR)
19-07-2011

Active ingredient:

карглумова киселина

Available from:

Recordati Rare Diseases

ATC code:

A16AA05

INN (International Name):

carglumic acid

Therapeutic group:

Други стомашно-чревния тракт и обмяната на веществата средства,

Therapeutic area:

Amino Acid Metabolism, Inborn Errors; Propionic Acidemia

Therapeutic indications:

Carbaglu е показан при лечението на:hyperammonaemia връзка до n-acetylglutamate-синтазы първичен дефицит;hyperammonaemia поради изовалериановой acidaemia;hyperammonaemia поради methymalonic acidaemia;hyperammonaemia за сметка на пропионова acidaemia.

Product summary:

Revision: 19

Authorization status:

упълномощен

Authorization date:

2003-01-24

Patient Information leaflet

                                20
Б. ЛИСТОВКА
21
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
CARBAGLU 200 MG ДИСПЕРГИРАЩИ СЕ ТАБЛЕТКИ
карглумова киселина (carglumic acid)
ПРОЧЕТЕТЕ ВНИМАТЕЛНО ЦЯЛАТА ЛИСТОВКА,
ПРЕДИ ДА ЗАПОЧНЕТЕ ДА ПРИЕМАТЕ ТОВА
ЛЕКАРСТВО,
ТЪЙ КАТО ТЯ СЪДЪРЖА ВАЖНА ЗА ВАС
ИНФОРМАЦИЯ.
-
Запазете тази листовка. Може да имате
нужда да я прочетете отново.
-
Ако имате някакви допълнителни
въпроси, попитайте Вашия лекар или
фармацевт.
-
Това лекарство е предписано лично на
Вас. Не го преотстъпвайте на други
хора. То може
да им навреди, независимо че
признаците на тяхното заболяване са
същите като Вашите.
-
Ако получите някакви нежеланите
реакции, уведомете Вашия лекар или
фармацевт. Това
включва и всички възможни нежелани
реакции, неописани в тази листовка.
Вижте точка 4.
КАКВО СЪДЪРЖА ТАЗИ ЛИСТОВКА
:
1.
Какво представлява Carbaglu и за какво се
използва
2.
Какво трябва да знаете, преди да
приемете Carbaglu
3.
Как да приемате Carbaglu
4.
Възможни нежелани реакции
5
Как да съхранявате Carbaglu
6.
Съдържание на опаковката и
допълнителна информация
1.
КАКВО ПРЕДСТАВЛЯВА CARBAGLU И ЗА КАКВО СЕ
ИЗПОЛЗВА
Carbaglu може да помогне за премахване на
прекомерно високите плазмени нива на
амоняк

                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
_ _
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Carbaglu 200 mg диспергиращи се таблетки
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всяка таблетка съдържа 200 mg карглумова
киселина (
_carglumic acid_
).
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Диспергираща се таблетка
Таблетките са бели и продълговати с
три делителни черти, и са гравирани от
едната страна.
Таблетката може да се раздели на две
равнидози.
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Carbaglu е показан при лечение на
•
хиперамонемия, дължаща се на първичен
дефицит на N-ацетилглутамат синтаза.
•
хиперамонемия, дължаща се на
изовалерианова ацидемия.
•
хиперамонемия, дължаща се на
метилмалонова ацидемия.
•
хиперамонемия, дължаща се на
пропионова ацидемия.
4.2
ДОЗИРОВКА И НАЧИН НА ПРИЛОЖЕНИЕ
Лечение с Carbaglu трябва да се започне
под наблюдението на лекар с опит в
лечението на
метаболитни нарушения.
Дозировка
•
За дефицит на N-ацетилглутамат
синтаза:
На базата на клиничния опит лечението
може да се започне още от първия ден на
живота.
Началната дневна доза трябва да бъде
от 100 mg/kg, до 250 mg/kg, ако се налага.
След това д
                                
                                Read the complete document

Similar products

Active ingredient карглумова киселина

карглумова киселина

ATC code A16AA05

A16AA05

Marketed by Recordati Rare Diseases

Recordati Rare Diseases

INN (International Name) carglumic acid

carglumic acid

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 19-07-2023
Summary of Product characteristics Summary of Product characteristics Spanish 19-07-2023
Public Assessment Report Public Assessment Report Spanish 19-07-2011
Patient Information leaflet Patient Information leaflet Czech 19-07-2023
Summary of Product characteristics Summary of Product characteristics Czech 19-07-2023
Public Assessment Report Public Assessment Report Czech 19-07-2011
Patient Information leaflet Patient Information leaflet Danish 19-07-2023
Summary of Product characteristics Summary of Product characteristics Danish 19-07-2023
Public Assessment Report Public Assessment Report Danish 19-07-2011
Patient Information leaflet Patient Information leaflet German 19-07-2023
Summary of Product characteristics Summary of Product characteristics German 19-07-2023
Public Assessment Report Public Assessment Report German 19-07-2011
Patient Information leaflet Patient Information leaflet Estonian 19-07-2023
Summary of Product characteristics Summary of Product characteristics Estonian 19-07-2023
Public Assessment Report Public Assessment Report Estonian 19-07-2011
Patient Information leaflet Patient Information leaflet Greek 19-07-2023
Summary of Product characteristics Summary of Product characteristics Greek 19-07-2023
Public Assessment Report Public Assessment Report Greek 19-07-2011
Patient Information leaflet Patient Information leaflet English 19-07-2023
Summary of Product characteristics Summary of Product characteristics English 19-07-2023
Public Assessment Report Public Assessment Report English 19-07-2011
Patient Information leaflet Patient Information leaflet French 19-07-2023
Summary of Product characteristics Summary of Product characteristics French 19-07-2023
Public Assessment Report Public Assessment Report French 19-07-2011
Patient Information leaflet Patient Information leaflet Italian 19-07-2023
Summary of Product characteristics Summary of Product characteristics Italian 19-07-2023
Public Assessment Report Public Assessment Report Italian 19-07-2011
Patient Information leaflet Patient Information leaflet Latvian 19-07-2023
Summary of Product characteristics Summary of Product characteristics Latvian 19-07-2023
Public Assessment Report Public Assessment Report Latvian 19-07-2011
Patient Information leaflet Patient Information leaflet Lithuanian 19-07-2023
Summary of Product characteristics Summary of Product characteristics Lithuanian 19-07-2023
Public Assessment Report Public Assessment Report Lithuanian 19-07-2011
Patient Information leaflet Patient Information leaflet Hungarian 19-07-2023
Summary of Product characteristics Summary of Product characteristics Hungarian 19-07-2023
Public Assessment Report Public Assessment Report Hungarian 19-07-2011
Patient Information leaflet Patient Information leaflet Maltese 19-07-2023
Summary of Product characteristics Summary of Product characteristics Maltese 19-07-2023
Public Assessment Report Public Assessment Report Maltese 19-07-2011
Patient Information leaflet Patient Information leaflet Dutch 19-07-2023
Summary of Product characteristics Summary of Product characteristics Dutch 19-07-2023
Public Assessment Report Public Assessment Report Dutch 19-07-2011
Patient Information leaflet Patient Information leaflet Polish 19-07-2023
Summary of Product characteristics Summary of Product characteristics Polish 19-07-2023
Public Assessment Report Public Assessment Report Polish 19-07-2011
Patient Information leaflet Patient Information leaflet Portuguese 19-07-2023
Summary of Product characteristics Summary of Product characteristics Portuguese 19-07-2023
Public Assessment Report Public Assessment Report Portuguese 19-07-2011
Patient Information leaflet Patient Information leaflet Romanian 19-07-2023
Summary of Product characteristics Summary of Product characteristics Romanian 19-07-2023
Public Assessment Report Public Assessment Report Romanian 19-07-2011
Patient Information leaflet Patient Information leaflet Slovak 19-07-2023
Summary of Product characteristics Summary of Product characteristics Slovak 19-07-2023
Public Assessment Report Public Assessment Report Slovak 19-07-2011
Patient Information leaflet Patient Information leaflet Slovenian 19-07-2023
Summary of Product characteristics Summary of Product characteristics Slovenian 19-07-2023
Public Assessment Report Public Assessment Report Slovenian 19-07-2011
Patient Information leaflet Patient Information leaflet Finnish 19-07-2023
Summary of Product characteristics Summary of Product characteristics Finnish 19-07-2023
Public Assessment Report Public Assessment Report Finnish 19-07-2011
Patient Information leaflet Patient Information leaflet Swedish 19-07-2023
Summary of Product characteristics Summary of Product characteristics Swedish 19-07-2023
Public Assessment Report Public Assessment Report Swedish 19-07-2011
Patient Information leaflet Patient Information leaflet Norwegian 19-07-2023
Summary of Product characteristics Summary of Product characteristics Norwegian 19-07-2023
Patient Information leaflet Patient Information leaflet Icelandic 19-07-2023
Summary of Product characteristics Summary of Product characteristics Icelandic 19-07-2023
Patient Information leaflet Patient Information leaflet Croatian 19-07-2023
Summary of Product characteristics Summary of Product characteristics Croatian 19-07-2023

Search alerts related to this product

Alerts Carbaglu карглумова киселина carglumic acid

Carbaglu карглумова киселина carglumic acid

View documents history

Documents history Documents history

Carbaglu